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EC number: 268-500-3 | CAS number: 68109-88-6
Endpoint summary
Administrative data
Description of key information
SKIN IRRITATION
Irritating, New Zealand White, United States EPA, Paragraph 163.81-5 “Primary dermal irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978, Seifert 1982a
EYE IRRITATION
Irritating, New Zealand White, United States EPA, Paragraph 163.81-4 “Primary eye irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978, Seifert 1982b
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- According to OECD 404
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 October 1982 to 25 October 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Procedure similar to the proposed guidelines of the United States EPA, Paragraph 163.81-5 “Primary dermal irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978
- Deviations:
- yes
- Remarks:
- : the procedure was based upon the guideline but was not in every part identical.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : the animals were exposed to the test material for 24 hours in an occlusive fashion; there was no evaluation 60 minutes after patch removal and the observation period lasted only 7 days.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Housing: Individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, ad libitum.
- Water (e.g. ad libitum): ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): Approximately 15 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light per day.
IN-LIFE DATES: From: 18 October 1982 To: 25 October 1982 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- - Volume: 0.5 mL of the test material
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6; 3 male and 3 female
- Details on study design:
- SITE PREPARATION:
-24 hours before exposure, the flanks of the test animals were shaved using an electric clipper. Immediately prior to treatment, the skin on one side was slightly scarified by means of a "Schroepfschnaepper".
TEST SITE
- Patch Size: Gauze patches 2.5 x 2.5 cm soaked with the test material were applied to intact and abraded skin sites. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
SCORING SYSTEM: The skin reactions were assessed upon patch removal and during the subsequent 7 day observation period in accordance with the Draize scale (1977). - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24 and 72 hour evaluations
- Score:
- 5.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Both shaved and abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Shaved skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.9
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Shaved skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Abraded skin
- Irritant / corrosive response data:
- Necrosis and extended erythema was observed in all 6 animals.
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Classified according to EU criteria.
- Conclusions:
- Under the conditions of the study, the test material was shown to cause marked irritation to the skin of rabbits and as such is classified as a category 2 skin irritant in accordance with EU criteria.
- Executive summary:
The skin irritancy potential of the test material was assessed in a GLP compliant in vivo study that was based upon the procedure outlined in the guidelines of the United States EPA, Paragraph 163.81-5 “Primary dermal irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978.
Six New Zealand White rabbits were exposed to the test material in an occlusive fashion for 24 hours on both intact and abraded skin. The skin reactions were evaluated in accordance with the Draize scale at 24, 48 and 72 hours followed by observations after 4 and 7 days.
Under the conditions of this study, the test material produced marked irritation to the skin and as such requires classification as “Category 2, H315: Causes skin irritation” with signal word “Warning” in accordance with EU criteria.
Reference
Table 1 PII at 24 and 72 hours.
PII = total ÷ 4
| Time After Exposure (hours) | Mean Erythema Scores | Mean Oedema Scores | ||
| Intact Skin | Abraded Skin | Intact Skin | Abraded Skin | |
| 24 | 3.0 | 3.0 | 2.8 | 2.7 |
| 72 | 3.0 | 2.8 | 2.7 | 2.5 |
| Subtotal | 6.0 | 5.8 | 5.5 | 5.2 |
| Total | 22.5 | |||
| PII | 5.6 | |||
Table 2 Individual Scores
Shaved
| Time After Exposure (hours) | Male | Female | Average | |||||
| 1 | 2 | 3 | 1 | 2 | 3 | |||
| Erythema | 24 hours | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 |
| 48 hours | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | |
| 72 hours | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | |
| 4 days | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | |
| 7 days | 3 | 2 | 3 | 2 | 2 | 3 | 2.5 | |
| Oedema | 24 hours | 3 | 3 | 3 | 2 | 3 | 3 | 2.8 |
| 48 hours | 3 | 2 | 2 | 2 | 3 | 3 | 2.5 | |
| 72 hours | 4 | 2 | 2 | 2 | 3 | 3 | 2.7 | |
| 4 days | 4 | 2 | 2 | 2 | 3 | 3 | 2.7 | |
| 7 days | 4 | 2 | 2 | 2 | 2 | 2 | 2.3 | |
| Abraded | ||||||||
| Erythema | 24 hours | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 |
| 48 hours | 2 | 3 | 3 | 3 | 3 | 3 | 2.8 | |
| 72 hours | 2 | 3 | 3 | 3 | 3 | 3 | 2.8 | |
| 4 days | 2 | 3 | 3 | 3 | 3 | 3 | 2.8 | |
| 7 days | 2 | 2 | 3 | 2 | 2 | 2 | 2.2 | |
| Oedema | 24 hours | 2 | 3 | 3 | 2 | 3 | 3 | 2.7 |
| 48 hours | 2 | 2 | 3 | 2 | 3 | 3 | 2.5 | |
| 72 hours | 2 | 2 | 4 | 2 | 3 | 2 | 2.5 | |
| 4 days | 2 | 2 | 4 | 2 | 3 | 2 | 2.5 | |
| 7 days | 2 | 2 | 3 | 1 | 2 | 2 | 2.0 | |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- According to OECD 405
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 October 1982 to 25 October 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Procedure similar to the proposed guidelines of the United States EPA, Paragraph 163.81-4 “Primary eye irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978
- Deviations:
- yes
- Remarks:
- The procedure was based upon the guideline but was not in every part identical.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The animals were not evaluated 60 minutes after exposure and the observation period lasted only 7 days.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Housing: Individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): Approximately 15 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light per day.
IN-LIFE DATES: From: 18 October 1982 To: 25 October 1982 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye of each animal remained untreated and served as concurrent control.
- Amount / concentration applied:
- - Volume: 0.1 mL
- Duration of treatment / exposure:
- After insertion of the test material into the conjunctival sac, the eyelids were gently closed for 15 seconds.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 9; 6 male and 3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 of the 9 rabbits the eye was flushed with 10 mL of sterile physiological saline
- Time after start of exposure: approximately 30 seconds after treatment
SCORING SYSTEM:
- Eyes were scored according to the Draize scale (1977)
TOOL USED TO ASSESS SCORE: slit-lamp - Irritation parameter:
- other: PII
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 29.6
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- other: PII
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 22.1
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.9
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Rinsed eyes
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Unrinsed eyes
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Rinsed eyes
- Irritant / corrosive response data:
- The test material was found to cause moderate irritation.
- Other effects:
- No other effects reported.
- Interpretation of results:
- other: Classified as Category 2 according to EU criteria.
- Conclusions:
- Under the conditions of the test, the test material was shown to be irritating to the eyes. In accordance with EU criteria the test material is classified as Category 2.
- Executive summary:
The eye irritancy potential of the test material was assessed in a GLP compliant in vivo study that was based upon the procedure outlined in the guidelines of the United States EPA, Paragraph 163.81-4 “Primary eye irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978.
Nine New Zealand White rabbits were exposed to the test material; the treated eye of three animals was rinsed with saline 30 seconds after exposure. The reactions to the test material were evaluated in accordance with the Draize scale (1977) after 24, 48 and 72 hours followed by further observations after 4 and 7 days. The test material was determined to cause moderate irritation.
Under the conditions of this study, the test material was shown to cause irritation to the eye which would require classification under regulation directive 1272/2008. The test material requires classification as "Category 2, H319: Causes serious eye irritation" with signal word "Warning".
Reference
Table 1 Calculation of Primary Eye Irritation Index
| Time After Exposure | Mean Reaction Score | |||||
| Unrinsed Eyes | Rinsed Eyes | |||||
| Cornea | Iris | Conjunctiva | Cornea | Iris | Conjunctiva | |
| 24 hrs | 11.7 | 2.5 | 17.0 | 10.0 | 0.0 | 16.0 |
| 48 hrs | 13.3 | 2.5 | 16.7 | 10.0 | 0.0 | 18.0 |
| 72 hrs | 14.2 | 2.5 | 16.7 | 10.0 | 0.0 | 15.3 |
| 4 days | 14.2 | 2.5 | 14.0 | 8.3 | 0.0 | 10.0 |
| 7 days | 10.0 | 1.7 | 8.7 | 6.7 | 0.0 | 6.0 |
| Subtotal | 63.4 | 11.7 | 73.1 | 45.0 | 0.0 | 65.3 |
| Total | 148.2 | 110.3 | ||||
| PII | 29.6 | 22.1 | ||||
Table 2 Individual Irritation Scores at 24, 48, 72 hours and days 4 and 7
| Unrinsed | Rinsed | |||||||||||
| Observation Time | Observation | Male 1 | Male 2 | Male 3 | Female 1 | Female 2 | Female 3 | Average | Male 4 | Male 5 | Male 6 | Average |
| 24 hrs | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
| Iris | 1 | 1 | 1 | 0 | 0 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
| Conjunctivae | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | 3 | 3 | 3 | 3.0 | |
| Chemosis | 3 | 3 | 3 | 3 | 3 | 2 | 2.8 | 3 | 2 | 3 | 2.7 | |
| 48 hrs | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
| Iris | 1 | 1 | 1 | 0 | 0 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
| Conjunctivae | 3 | 3 | 3 | 3 | 3 | 2 | 2.8 | 3 | 3 | 3 | 3.0 | |
| Chemosis | 3 | 3 | 3 | 3 | 3 | 1 | 2.7 | 3 | 3 | 3 | 3.0 | |
| 72 hrs | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
| Iris | 1 | 1 | 1 | 0 | 0 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
| Conjunctivae | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | 3 | 3 | 3 | 3.0 | |
| Chemosis | 3 | 3 | 3 | 2 | 3 | 3 | 2.8 | 3 | 2 | 2 | 2.3 | |
| 4 days | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
| Iris | 1 | 0 | 1 | 0 | 1 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
| Conjunctivae | 3 | 3 | 2 | 3 | 3 | 3 | 2.8 | 2 | 2 | 2 | 2.0 | |
| Chemosis | 2 | 2 | 2 | 2 | 2 | 3 | 2.2 | 2 | 2 | 2 | 2.0 | |
| 7 days | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
| Iris | 1 | 0 | 1 | 0 | 0 | 0 | 0.3 | 0 | 0 | 0 | 0.0 | |
| Conjunctivae | 2 | 1 | 2 | 2 | 2 | 1 | 1.7 | 1 | 2 | 1 | 1.3 | |
| Chemosis | 2 | 1 | 2 | 2 | 2 | 1 | 1.7 | 1 | 1 | 1 | 1.0 | |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
In the GLP compliant key study, the skin irritancy potential of the test material was assessed in vivo using a method based upon the procedure outlined in the guidelines of the United States EPA, Paragraph 163.81-5 “Primary dermal irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978.
Six New Zealand White rabbits were exposed to the test material in an occlusive fashion for 24 hours on both intact and abraded skin. The skin reactions were evaluated in accordance with the Draize scale at 24, 48 and 72 hours followed by observations after 4 and 7 days.
Under the conditions of this study, the test material produced marked irritation to the skin.
The study was performed to a good standard with a sufficient level of detail to assess the quality of the study. As such it was assigned a reliability score of 2 using the principles for assessing data quality as set out in Klimisch (1997) and considered suitable as an accurate reflection of the test material.
Eye Irritation
In the GLP compliant key study, the skin irritancy potential of the test material was assessed in vivo using a method based upon the procedure outlined in the guidelines of the United States EPA, Paragraph 163.81-4 “Primary eye irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978.
Nine New Zealand White rabbits were exposed to the test material; the treated eye of three animals was rinsed with saline 30 seconds after exposure. The reactions to the test material were evaluated in accordance with the Draize scale (1977) after 24, 48 and 72 hours followed by further observations after 4 and 7 days. The test material was determined to cause moderate irritation under the conditions of the study.
The study was performed to a good standard with a sufficient level of detail to assess the quality of the study. As such it was assigned a reliability score of 2 using the principles for assessing data quality as set out in Klimisch (1997) and considered suitable as an accurate reflection of the test material.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available.
Justification for selection of eye irritation endpoint:
Only one study available.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Skin Irritation
The skin irritation study indicates that the test material requires classification under regulation 1272/2008. The test material requires classification as “Category 2, H315: Causes skin irritation” with signal word “Warning”.
Eye Irritation
The eye irritation study indicates that the test material requires classification under regulation 1272/2008. The test material requires classification as “Category 2, H319: Causes serious eye irritation" with signal word " Warning".
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.
