Registration Dossier
Registration Dossier
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EC number: 701-365-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Taking data from both skin and eye irritation/corrosion studies into account, it can be concluded that the test substance is non-irritating to rabbit skin and eye.
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:
- 17 to 20 March 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Federal Register 38, No 187
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Site of test substance application was abraded representing an elevated testing condition compared to intact skin.
- Principles of method if other than guideline:
- FDA Federal Register 38, No 187, Patch-Test, occusive scarified and intact skin
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 1.6 to 2.1 kg
- Housing: single
- Diet (ad libitum): Standard food ERKA 8300
- Water (ad libitum): tap water
- Acclimation period: NA
IN-LIFE DATES: From: 17. March To: 20. March 1980 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded areas
- Vehicle:
- physiological saline
- Controls:
- not specified
- Amount / concentration applied:
- 2 x 500 mg moistened with 0.2 mL physiological saline solution (abraded and intact skin)
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- The flank skin was shaved at an area of 6 cm x 3 cm. One half of 3 x 3 cm was abraded by means of a scarificator. A gauze pad (2.5x2.5 cm) with 500 mg pasted test substance was applied to each 3x3 cm test area.
TEST SITE
- Area of exposure: 2 x 3 cm x 3 cm
- Type of wrap if used: polyethylene film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours
SCORING SYSTEM: - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- shaved skin
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 hours
- Irritation parameter:
- edema score
- Remarks:
- shaved skin
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 hours
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Slightly irritating according to Federal Register 38, No 187. No labelling according to EU guideline
- Executive summary:
Acute dermal skin irritation/corrosion study in the rabbits was carried out with a procedure similar to OECD guideline 404. 6 rabbits were treated on abraded skin with the test substance for 24 h and observation upto 72 h. The flank skin was shaved at an area of 6 cm x 3 cm. One half of 3 x 3 cm was abraded by means of a scarificator. A gauze pad (2.5x2.5 cm) with 500 mg pasted test substance was applied to each 3x3 cm test area.
Overall mean irritation score noted was 3 wherein the reactions were not fully reversible within 72 h.Primary irritation index score was 2.96.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10. Nov. to 13. Nov 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.1 - 2.4 kg
- Housing: single
- Diet (ad libitum): Altromin 2123
- Water (ad libitum): deionized chlorated water from automated supply
- Acclimation period: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10. Nov To: 13. Nov. 1987 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm²
- Type of wrap if used: semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours
EVALUATION TIME
30-60 minutes, 24, 48, 72 hours after removal of bandage
SCORING SYSTEM: according to test guideline - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- no signs of irritation observed
- Other effects:
- light blue staining of test site
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test item has not to be classified as skin irritant. No labelling required.
- Executive summary:
A GLP-compliant acute dermal skin irritation/corrosion study in the rabbits was performed according to OECD guideline 404. 3 rabbits were treated on shaved skin with the test substance for 4 h and observation up to 72 h. No signs of irritation observed other than light blue staining of test site.
The mean edema and erythema score noted was 0.
Referenceopen allclose all
| Time after application | 24 h | 48 h | 72 h | ||||||||||||||||
| Animal number | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | |
| abraded | erythema | 2 | 2 | 4 | 2 | 1 | 2 | 2 | 1 | 3 | 1 | 1 | 2 | 2 | 1 | 2 | 1 | 1 | 2 |
| edema | 2 | 2 | 2 | 2 | 2 | 3 | 2 | 1 | 1 | 2 | 1 | 2 | 2 | 1 | 1 | 1 | 0 | 2 | |
| shaved | erythema | 2 | 1 | 2 | 1 | 1 | 2 | 2 | 1 | 2 | 1 | 0 | 2 | 2 | 1 | 2 | 0 | 0 | 2 |
| edema | 2 | 1 | 3 | 1 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | |
| sum | 46 | 29 | 25 | ||||||||||||||||
| primary irritation index (24+72) | 2.96 | ||||||||||||||||||
Classification Index:
0.0 to 0.5 non irritant
0.6 to 3.0 slightly irritant
3.1 to 5.0 moderately irritant
5.1 to 8.0 severely irritant
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:
- 17 to 20 March 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No 187
- Principles of method if other than guideline:
- Federal Register 38, No 187
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 1.6 to 2.1 kg
- Housing: single
- Diet (e.g. ad libitum): Standard food ERKA 8300
- Water (e.g. ad libitum): tap water
- Acclimation period: NA
IN-LIFE DATES: From: 17. March To: 20. March 1980 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg pasted with 1 drop physiological saline solution
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test item was applied to the left eye of each rabbit. The contra-lateral eye served as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: conjunctiva discharge
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Other effects:
- no effects
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is determined to be not irritating to rabbit eye. Classification according to EC: not irritating
- Executive summary:
Acute eye irritation/corrosion study in the rabbits was performed following procedure mentioned in Federal Register 38, No.178. Six rabbits were treated with the test substance for 24 h and observation upto 72 h.The test item was applied to the left eye of each rabbit. The contra-lateral eye served as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.
Maximum mean total score (MMTS) after 72 h was observed to be 1 on a scale of 110.
Based on the score, the test substance is determined to be not irritating to rabbit eye.
Reference
Classification Index
0-10 non irritating
11-25 slightly irritating
26-56 moderately irritating
57-110 severely irritating
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A GLP compliant acute dermal skin irritation/corrosion study in the rabbits was performed according to OECD guideline 404. 3 rabbits were treated on shaved skin with the test substance for 4 h and observation up to 72 h. No signs of irritation observed other than light blue staining of test site. The mean oedema and erythema score noted was 0.
A study similar to OECD guideline 404 performed with 6 rabbits, over all mean irritation score noted was 3 wherein the reactions were not fully reversible within 72 h. Primary irritation index score was 2.96. According to the results of this study the test substance is slightly irritating according to Federal Register 38, No 187. No labelling required according to EU guideline. It can be noted that abrasion on skin causes epidermal injury and further expected to cause the skin irritation and adverse effects to epidermis. This reaction could be referred to the damage caused due to abrasion rather than due to the test substance application. In general abrasion is an elevated testing condition and results normally do not have to be taken into account for hazard assessment. Hence, can be concluded as not irritating to rabbit skin.
In a Barail-Test intracutaneous injection of 0.02 ml of an aqueous solution with 0.01 %, 0.1 %, 1 %, 10 % test item concentration or physiological saline (control) were given to 3 rabbits. In addition, cutaneous administration of 0.5 ml of the 10 % preparation was applied to depilated flank skin of another 3 animals. The animals were observed up to 4 days. No irritation and other effects were observed. The overall mean irritation score was noted to be 0. Hence, test substance is determined as not irritating to rabbit skin.
Two other studies performed in the 1960ies and 1970ies reported the test substance as not irritating to rabbit skin.
Taking into consideration the results from the key study and other support studies the test substance can be determined to be not irritating to rabbit skin.
Eye Irritation:
Two acute eye irritation/corrosion studies were performed following procedure mentioned in Federal Register 38, No.178. Six rabbits were treated with the test substance for 24 h and observation up to 72 h. Maximum mean total score (MMTS) after 72 h was observed to be 0 and 1 on a scale of 110 respectively. Based on the score, the test substance is determined to be not irritation to eye.
Taking the results from the above mentioned studies into consideration, the test substance can be determined to be not irritating to rabbit eye.
Justification for selection of skin irritation / corrosion
endpoint:
Guideline study in compliance to GLP
Justification for selection of eye irritation endpoint:
Guideline similar to OECD.
Justification for classification or non-classification
Based on the finding in the skin and eye irritation studies, the test substance does not need to be classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.
