Registration Dossier
Registration Dossier
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EC number: 942-100-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin Irritation: Not Irritant
Eye Irritation: Not Irritant
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:
- key study
- Study period:
- October 21, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Pre GLP.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK ltd.
- Weight at study initiation: 3.4 - 3.8 kg
- Housing: in individual cages (Drahtkäfige type III-Hoch)
- Diet (e.g. ad libitum): standard diet "Sniff K4" (Versuchstierdiäten GmbH) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 45 - 64 %
- Air changes : 10 canges per day
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
500 mg of test substance have been dissolved in water and applied on rabbits - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 male
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Beiersdorf No. 2342
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 h - Irritation parameter:
- erythema score
- Basis:
- animal: L76
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: L76
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: L77
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: L77
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: K83
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: K83
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not irritant
- Executive summary:
The substance to be registered has been tested according to OECD 404. The test substance was applied on the shaved skin of three rabbits.
No erythema and no edema were observed during the test.
Reference
4h exposition data:
| animal n. | Sex/weight (kg) | DRAIZE -Grade after: | final values | ||||||||||
| 1h | 24h | 48h | 72h | 7d | |||||||||
| E | O | E | O | E | O | E | O | E | O | E | O | ||
| L76 | M/3.8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 |
| L77 | M/3.4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 |
| K83 | M/3.4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 |
| E = Erythema | |||||||||||||
| O = Oedema | |||||||||||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 21, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Pre GLP.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK ltd.
- Weight at study initiation: 3.4 - 3.8 kg
- Housing: in individual cages (Drahtkäfige type III-Hoch)
- Diet (e.g. ad libitum): standard diet "Sniff K4" (Versuchstierdiäten GmbH) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 45 - 64 %
- Air changes : 10 canges per day
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- not specified
- Controls:
- other: the not treated eye for each animal was used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing with physiological saline solution
- Time after start of exposure: 24h
SCORING SYSTEM: DRAIZE system
TOOL USED TO ASSESS SCORE: fluorescein and Optical devices - Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: No eye reaction
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: No eye reaction
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: 24 hours after the application of the substance, the redness reaction was not evaluable due to the blue coloration of the eye. In order to give an evaluation the score at 24 h was selected as the higher one of the Draize scale.
- Irritation parameter:
- conjunctivae score
- Remarks:
- oedema
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: No eye reaction
- Other effects:
- 24 hours after the application of the test substance, the redness of conjunctivae was not evaluable for the blue coloration of the eye.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The test substance is not irritant for the eye.
- Executive summary:
The substance to be registered wa tested according to OECD 405, during the test 3 rabbits were used (2 female and 1 male). 24 hours after the application of the test substance, the redness reaction was not evaluable due to the blue coloration of the eye. In order to give an evaluation the score at 24 h was selected as the higher one of the Draize scale. No other effects were observed during the test.
According to the CLP Regulation the substance is not irritant for eye.
Reference
| animal n. | Sex/weight (kg) | organs | symptoms | DRAIZE -Grade after: | final values | ||||
| 1h | 24h | 48h | 72h | 7d | |||||
| M59 | ♀/3.2 | cornea | Opacity | 0 | 0 | 0 | 0 | 0 | 0.0 |
| Surface | 0 | 0 | 0 | 0 | 0 | ||||
| iris | 0 | 0 | 0 | 0 | 0 | 0.0 | |||
| conjunctivae | Redness | X | X | 0 | 0 | 0 | X | ||
| Swelling | 1 | 0 | 0 | 0 | 0 | 0.0 | |||
| Lacrimation | 1 | 0 | 0 | 0 | 0 | ||||
| M61 | ♀/3.4 | cornea | Opacity | 0 | 0 | 0 | 0 | 0 | 0.0 |
| Surface | 0 | 0 | 0 | 0 | 0 | ||||
| iris | 0 | 0 | 0 | 0 | 0 | 0.0 | |||
| conjunctivae | Redness | X | X | 0 | 0 | 0 | X | ||
| Swelling | 1 | 0 | 0 | 0 | 0 | 0.0 | |||
| Lacrimation | 2 | 0 | 0 | 0 | 0 | ||||
| K63 | ♂/4.7 | cornea | Opacity | 0 | 0 | 0 | 0 | 0 | 0.0 |
| Surface | 0 | 0 | 0 | 0 | 0 | ||||
| iris | 0 | 0 | 0 | 0 | 0 | 0.0 | |||
| conjunctivae | Redness | X | X | 0 | 0 | 0 | X | ||
| Swelling | 0 | 0 | 0 | 0 | 0 | 0.0 | |||
| Lacrimation | 1 | 0 | 0 | 0 | 0 | ||||
| X = evaluation not feasible for blue coloration | |||||||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The assessment for skin and eye irritation was conducted in several test on rabbits. All the existing studies show skin and eyes reaction associated with primary irritation score consistent with each other.
The key studies have been conducted according to GLP and to the internationally accepted guidelines.
Justification for classification or non-classification
Skin Irritation
According to the CLP Regulation (EC n. 1272/2008), skin corrosion means the production of irreversible damage to the skin, and skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
A substance has to be classified as Category 1 (Corrosive) if there is the production of irreversible damage to the skin in more than 1 of three animals.
A substance has to be classified as Category 2 (Irritant) if shows:
(1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
The oedema reaction, in one test (Huntsman Textile Effects GmbH, 1975) was not fully reversible within 72 hours on abraded skin but fully reversible within 72 hours on intact skin. According to the ECHA Guidance on the application of Regulation (EC) n. 1272/2008, the calculation of mean scores should normally be restricted to the results obtained from intact skin. The means for the other tests did not exceed the 2.3 value, and there was not pronounced variability of response among animals therefore the test substance has not need to be classified.
Eye Irritation
According to the CLP Regulation (EC n. 1272/2008), Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application
Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.
A substance has to be classified as Category 1 (Irreversible effects on the eye), If, when applied to the eye of an animal, a substance produces:
— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 3 and/or
— iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
A substance has to be classified as Category 2 (irritating to eye) if, when applied to the eye of an animal, a substance produces:
at least in 2 of 3 tested animals, a positive response of:
- corneal opacity ≥ 1 and/or
- iritis ≥ 1, and/or
- conjunctival redness ≥ 2 and/or
- conjunctival oedema (chemosis) ≥ 2
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
Based on the provided data no classification for eye irritation is warranted under the CLP Regulation.
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.
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