Registration Dossier
Registration Dossier
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EC number: 235-546-0 | CAS number: 12270-13-2
Endpoint summary
Administrative data
Description of key information
Studies conducted with the target substance in a formulation and data from a suitable structural analogue (chloride salt) were evaluated in a weight-of-evidence approach. The source substance was tested negative for acute dermal irritating properties in studies conducted according or equivalent to OECD test guideline 404 showing that the chromophore itself is not showing skin irritating effects.
Studies conducted with the target substance showed different effects on skin. Based on the study of Eroler, 1977, the target substance can be considered as non-irritating. In contrast to this, the study conducted by Jäckh, 1981 with the target substance in a formulation containing free acetic acid , showed irritating effects on skin, which were not fully reversible after 8 days.
Studies conducted according to or equivalent to OECD test guideline 405 are available for the source substance to assess the eye irritating potential. In two studies the source substance showed irritating effects (Seifert, 1982; Braun 1995), showing that the chromophore itself has the potential to induce eye irritation. Two in vivo eye irritation studies were conducted with the target substance (containing 30% formic acid), showing severe irritant effects.
However, as the substance is marketed as aqueous solution containing significant concentrations of free acetic acid as stabiliser, classification based on the specific concentration limits of acetic acid do apply.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977-06-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- observation period 24 h, 72 h and 7 days
- Principles of method if other than guideline:
- Test was conducted according to US FDA, Federal Register 38 No. 187 § 1500.41 (Skin), p. 27019 from 27 September 1973
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS: albino rabbits
- Weight at study initiation: 3-4 kg
- Housing: cages: stainless steel without litter
- Diet (e.g. ad libitum): standard pellet diet for rabbits, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23 °C
- Humidity (%): 50-70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 h and 72 h after start of application, if findings additional observation after 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Upper third of the back caudal to the ribs, ca. 2.5 x 2.5 cm
- Type of wrap if used: Gauze (2 layers 2.5 x 2.5 cm). The gauze was fastened with an elastic bandage. In addition, the hull was wrapped in PVC foil.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, dyes are washed off with warm water or lutrol-water mixture.
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS
- 24 and 72 hours (in case of findings, additional observation after 7 days)
SCORING SYSTEM:
- Method of calculation: Method according to Draize (see Table 1 in box "Any other information on materials & methods incl. tables") - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24 h
- Remarks on result:
- other: skin was stained blue by the test material and thus the erythema score could not be obtained.
- Irritation parameter:
- erythema score
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 72 h
- Remarks on result:
- other: skin was stained blue by the test material and thus the erythema score could not be obtained
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- other:
- Remarks:
- mean of 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- An evaluation of erythema was not possible due to the intense blue coloration. The evaluation of the irritation index is therefore only based on the edema. Based on the results the test item is considered to be non-irritant.
For individual results see Table 2 in box "Any other information on results incl. tables". - Other effects:
- no
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results from an in vivo acute dermal irritation/corrosion study, the test item can be considered as non-irritanting to the skin.
- Executive summary:
In a primary dermal irritation study (conducted equivalent to OECD 404), six albino rabbits were dermally exposed to 0.5 mL of the test item for 24 hours to an area of exposure of 6.25 cm² under occlusive conditions. Animals then were observed for a total of 72 hours. Irritation was scored by the method of Draize. An evaluation of erythema was not possible due to an intense blue colouration of the skin by the test material. Based on the results, the test item can be considered to be non-irritating to the skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1981-09-09 to 1981-12-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no observation after 72 hours and 14 days, but after 24 h, 48 h and 8 days after start of application; occlusive coverage
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, Germany
- Weight at study initiation: mean: 2.65 kg (male), 2.98 kg (female)
- Housing: One animal per cage, cages: stainless steel with wire inlays, base area 40 x 51 cm
- Diet (e.g. ad libitum): ad libitum, ca. 130 g per animal per day, diet: Ovator Solikanin 4 MM, Muskator Werke, Düsseldorf, Germany
- Water (e.g. ad libitum): ad libitum, 250 mL per animal per day, Monday-Friday: VE-water, Saturday-Sunday: tap water
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 3 minutes and 4 hours
- Observation period:
- 8 days
- Number of animals:
- Three minutes experiment: 2 (1 male /1 female)
Four hours experiment: 4 ( 2 males, 2 females) - Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm; upper third of the back or flank
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lutrol and lutrol/water (1:1)
- Time after start of exposure: 3 minutes and 4 hours
OBSERVATION TIME POINTS
30-60 min after exposure period and 24, 48 and 8 days after start of application
SCORING SYSTEM:
- Method of calculation: Scoring according to the Method of Draize (see Table 1 in box “Any other information on materials & methods incl. tables”) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- other: skin was stained blue by the test material and thus the erythema score could not be obtained.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- other: skin was stained blue by the test material and thus the erythema score could not be obtained.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 8 days
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Remarks on result:
- other: skin was stained blue by the test material and thus the erythema score could not be obtained.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Remarks on result:
- other: skin was stained blue by the test material and thus the erythema score could not be obtained.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: positive indication of irritation, 72 hour time point not assessed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 72 hour endpoint not assessed
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 72 hour endpoint not assessed
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Individual results are displayed in Table 2 and Table 3 in box "Any other information on results incl. tables". Some difficulty was experienced in assessing the erythema induced by the test item due to the blue colouration imparted to the skin. Only one animal could be examined for erythema. A well defined erythema was observed which was not fully reversible within 8 days. Further, very slight to moderate edema was observed. In one animal, edema was not fully reversible within 8 days.
Some animals showed crusts with intact skin underneath and scales. - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In this study, the test item is irritating to the skin. Due to methodological deficiencies, this study cannot be used for classification.
- Executive summary:
In a primary dermal irritation study four Vienna White rabbits were dermally exposed to a 0.5 mL of the test item to 2.5 x 2.5 cm of the body surface area for four hours. Test sites were covered with an occlusive dressing. Animals were observed for 8 days. Irritation was scored by the method of Draize. Well defined erythema and very slight to moderate edema were observed. The erythema and edema of one animal was not fully reversible within 8 days. In this animal also the development of a skin crust was seen. Below this crust the skin was intact. In this study, the test item is considered to be irritating. The data cannot be used for a classification in accordance to the CLP due to methodological deficiencies.
Referenceopen allclose all
Table 2: Individual irritation score
| Time after start of application | Animal no. | |||||||
| Erythema score | 1 | 2 | 3 | 4 | 5 | 6 | Mean 24-72 h | |
| 24 | * | * | * | * | * | * | * | |
| 72 | * | * | * | * | * | * | * | |
| Edema score | 24 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 72 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
* = dark blue staining
| Table 2: Individual irritation scores after 3 minutes exposure | ||||
| Time | Animal No. | Erythema | Edema | Symptoms |
| 24 hours | 1 | * | 1 | SO |
| 2 | * | 1 | SO | |
| 48 hours | 1 | * | 1 | SO |
| 2 | * | 1 | SO | |
| 8 days | 1 | 0 | 0 | S |
| 2 | 0 | 0 | S | |
Table 3: Individual irritation scores after 4 h exposure
| Time | Animal No. | Erythema | Edema | Symptoms |
| 24 hours | 1 | * | 1 | S0 |
| 2 | 2 | 2 | R:U/OE:U | |
| 3 | * | 1 | S0 | |
| 4 | * | 1 | S0 | |
| 48 hours | 1 | * | 1 | S0 |
| 2 | 2 | 2 | R:U/OE:U | |
| 3 | * | 0 | S0 | |
| 4 | * | 0 | S0 | |
| 8 days | 1 | 0 | 0 | S/+ |
| 2 | 2 | 1 | S2/+ | |
| 3 | * | 0 | S0/S | |
| 4 | * | 0 | S0/S |
* not readable (see symptoms)
S0 - not readable due to stained skin by dye
S2 - crust (lens-sized)
OE:U - edema
R:U - erythema
S - scaling
+ - findings in agreement with pathological findings
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977-07-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observation period only max. 15 days
- Principles of method if other than guideline:
- Test was conducted according to US FDA, Federal Register 38 No. 187 § 1500.41 (Eye), p. 27019 from 27 September 1973
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: stainless steel cages, 1 animal per cage
- Diet (e.g. ad libitum): ad libitum, standard pellet diet for rabbits
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23 °C
- Humidity: 50-70%
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 72 hours, if irritation after 72 h was observed observation period was extended to 15 days.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Scoring according to the method of Draize (see Table 1 in box "Any other information on materials & methods incl. tables") - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Remarks on result:
- other: at 24 and 48 h investigation was not possible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Remarks on result:
- other: at 24 and 48 h investigation was not possible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Remarks on result:
- other: at 24 and 48 h investigation was not possible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.6
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3.6
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- During and after application, animals reacted with defensive movements and pinching of the eyes.
- 1 hour after application: no evaluation was possible, eyes were stained by the dye.
- 72 hours after application: Eyes were partially glued, slimy purulent
- 7 days after application: Cornea severely blind, slightly bluish, iris hardly recognizable, eyelids half to very closed with purulent discharge
- 15 days after application: In 1 rabbit the whole eye was rejected, in 2 other rabbits the eyes were atrophied. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the results from this study, the test item can be considered as severe eye irritant.
- Executive summary:
In a primary eye irritation study performed according to the Food and Drug Administration of the US FDA, Federal Register 38 No. 187 § 1500.41 (Eye), p. 27019 from 27 September 1973, 0.1 mL of the test substance was instilled into the conjunctival sac of 6 albino rabbits. Animals then were observed for max. 15 days. Irritation was scored by the method of Draize. Irritation was observed in all animals. 72 hours after application, eyes were partially glued and slimy purulent. 7 days after application the cornea was severely blind, slightly bluish, iris was hardly recognizable and eyelids half to very closed with purulent discharge. 15 days after application in 1 rabbit the whole eye was rejected, in 2 other rabbits the eyes were atrophied. Due to these irreversible effects, the test item is considered to be corrosive according to CLP criteria.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1981-09-08 to 1981-10-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only 15 d observation period
- Principles of method if other than guideline:
- Method according the Federal Regulations 38, No. 187, paragraph 1500.42, S. 27019 from 27.09.1973
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main
- Weight at study initiation: 2.59-3.48 kg (male), 2.04-2.64 kg (female)
- Housing: stainless steel with wire floor, base area: 40 x 51 cm, 1 animal per cage
- Diet (e.g. ad libitum): from: Ovator Solikanin 4 mm, Muskator-Werke, 4000 Düsseldorf-1; ca.130 g per animal per day
- Water (e.g. ad libitum): VE-water (Monday to Friday); tap water (Saturday and Sunday); ca. 250 mL per animal per day
- Acclimation period: ca. 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 15 days
- Number of animals or in vitro replicates:
- 6 (4 males, 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Scoring according to the Method of Draize (see Table 1 in "Any other information on materials and methods incl. tables)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Symptoms of suppuration, scarred retraction on the eyelid, narrowed pupil and staphyloma were observed. Cornea opacity, chemosis and conjunctivae redness was not reversible within 15 days. Please see Table 2 in box "Any other information on results incl. tables" for detailed results.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this study, the test item is considered to be corrosive to the eyes due to the severe effects still visible after 15 days.
- Executive summary:
In a primary eye irritation study performed according to the Food and Drug Administration of the US FDA, Federal Register 38 No. 187 § 1500.41 (Eye), p. 27019 from 27 September 1973, 0.1 mL of the test substance was instilled into the conjunctival sac of 6 albino rabbits. Animals then were observed for 15 days. Irritation was scored by the method of Draize. Irritation was observed in all animals. Symptoms of suppuration, scarred retraction on the eyelid, narrowed pupil and staphyloma were observed. Cornea opacity, chemosis and conjunctivae redness was not reversible within 15 days. Due to the irreversible effects which increased over time, the test item is considered to be corrosive.
Referenceopen allclose all
Table 2: Individual Eye Irritation Scores
| 24 hours after application | 48 hours after application | 72 hours after application | ||||||||||||||||
| Animal no. | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 |
| Cornea opacity | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 2 | 2 | 2 | 2 | 2 | 1 | 2 | 2 |
| Iris score | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Conjunctivae redness | * | 0 | 0 | 1 | * | * | * | 1 | 1 | 1 | * | * | 1 | 1 | 1 | 1 | 1 | 1 |
| Chemosis | 2 | 4 | 3 | 2 | 3 | 2 | 3 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 3 | 4 | 4 |
* Conjunctivae redness cannot be assessed
Table 2: Individual Eye Irritation Scores
| Observation time | Animal no. | Cornea opacity | Iritis | Conjunctivae redness | Chemosis | Symptoms |
| 24 hours | 1 | 1 | 0 | 2 | 2 | E/PV |
| 2 | 1 | 0 | 2 | 2 | E/PV/NA | |
| 3 | 1 | 0 | 2 | 2 | PV | |
| 4 | 1 | 0 | 2 | 2 | E/PV | |
| 5 | 1 | 0 | 2 | 3 | E/PV | |
| 6 | 1 | 0 | 2 | 3 | PV | |
| 48 hours | 1 | 1 | 1 | 2 | 2 | E/PV |
| 2 | 1 | 1 | 2 | 2 | E/PV/NA | |
| 3 | 1 | 1 | 1 | 1 | PV | |
| 4 | 1 | 1 | 1 | 1 | PV/NA | |
| 5 | 1 | 1 | 2 | 3 | E/PV | |
| 6 | 1 | 1 | 2 | 2 | PV | |
| 72 hours | 1 | 2 | 1 | 2 | 2 | E/PV/NA |
| 2 | 2 | 1 | 3 | 2 | E/PV/NA | |
| 3 | 2 | 1 | 2 | 1 | PV/NA | |
| 4 | 2 | 1 | 1 | 1 | PV/NA | |
| 5 | 2* | 1* | 2* | 3 | S1/E | |
| 6 | 2 | 1 | 2 | 1 | PV | |
| 8 days | 1 | 1 | 0 | 1 | 0 | NA |
| 2 | 2 | 0 | 2 | 2 | E/NA | |
| 3 | 2 | 0 | 2 | 1 | NA | |
| 4 | 2 | 0 | 2 | 2 | PV/NA | |
| 5 | 2 | 0 | 2 | 2 | E/NA | |
| 6 | 2 | 1 | 2 | 1 | PV/NA | |
| 15 days | 1 | 1 | 0 | 2 | 1 | NA |
| 2 | 4 | 0 | 2 | 2 | E/NA/ST | |
| 3 | 4 | 0 | 2 | 1 | E/NA/ST | |
| 4 | 2 | 0 | 1 | 1 | PV/NA | |
| 5 | 4 | 0 | 2 | 2 | E/NA/ST | |
| 6 | 2 | 0 | 2 | 1 | PV/NA/ST |
S1 - Score not readable due to suppuration
E - Suppuration
NA - Scarred retraction on the eyelid
PV - Narrowed pupil
ST - Staphyloma
* - if reading is not possible due to the same reason, the amounted entire mean value of the readable values will be used
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Studies conducted with the target substance and data from a suitable structural analogue (chloride salt) were evaluated in a weight-of-evidence approach. The source substance was tested negative for acute dermal irritating properties in studies conducted according to or equivalent to OECD testing guideline 404 showing that the chromophore itself is not showing any skin irritating effects.
Studies conducted with the target substance showed different effects on skin. Based on the results from Eroler, 1977, the target substance can be considered as non-irritating. In contrast to this, the study conducted by Jäckh, 1981 with the target substance in a formulation containing free acetic acid, showed irritating effects on skin, which were not fully reversible after 8 days.
Studies conducted according to or equivalent to OECD test guideline 405 are available for the source substance to assess the eye irritating potential. In two studies the source substance showed irritating effects (Seifert, 1982; Braun 1995), showing that the chromophore itself has the potential to induce eye irritation. Two in vivo eye irritation studies were conducted with the target substance, showing severe irritating effects.
As the substance is only markets as aqueous solution containing significant concentrations of free acetic acid as stabiliser, classification based on the specific concentration limits of acetic acid do apply. Thus, the target substance can be considered to causes severe skin burns and eye damage (Skin Corr 1B, H314).
Justification for classification or non-classification
As the substance is only sold in markets as aqueous solution containing significant concentrations of free acetic acid as stabiliser, classification based on the specific concentration limits of acetic acid do apply. Thus, the target substance can be considered to causes severe skin burns and eye damage (Skin Corr 1B, H314).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
