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EC number: 241-083-5 | CAS number: 17006-17-6
Endpoint summary
Administrative data
Description of key information
Skin irritation (rat): not irritating [Draft report, Stark 2001]
Eye irritation (rabbit): not irritating [Draft report, Wick 2002]
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:
- other information
- Study period:
- from September to October 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Comparable to guideline study with acceptable restrictions: A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting
- Species:
- rat
- Strain:
- other: Shoe:Wist
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: 0.9 % sodium chloride solution
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- 549-613 mg/male animal or 420-440 mg/female animal
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males and 3 females
- Executive summary:
A combined study on acute dermal toxicity and on local tolerance was conducted . The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion. In this studya single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg was tolerated without any local irritations.
Reference
No relevant compound-related local findings were observed. The only finding was the occurrence of substance remains in male rats up to day 4, with the distribution ranging from spotty to covering the whole administration area.
The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.
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:
- other information
- Study period:
- November 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - 4 instead of 3 animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- test substance remained in the eye (eye was not rinsed)
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 2 males and 2 females
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.58
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 3 days
- Executive summary:
In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight irritation which was fully reversible 7 days after treatment at the latest. The calculation of mean values of the findings according to the system of evaluation recommended for the EU (1) revealed 0 for the parameter cornea and iris,0.17 for conjunctival swelling and 0.58 for conjunctival reddening.. According to EU classification criteria the test substance need not be labelled as an eye irritant.
Reference
Table 1: Results of the study
Irritant effects (score) |
|||||
Animal no. (sex) |
Irritation parameter |
24 h | 48 h | 72 h | Mean scores |
1 (M) |
Cornea |
0 | 0 | 0 | 0.0 |
Iris |
0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) |
1 | 0 | 0 | 0.33 | |
Conjunctiva (swelling) |
0 | 0 | 0 | 0.0 | |
2 (M) |
Cornea |
0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 1 | 1 | 1 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
3 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
4 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 1 | 1 | 1 | |
| Conjunctiva (swelling) | 1 | 1 | 0 | 0.66 | |
The control eyes were without findings.
Local findings after single administration of the test substance into the conjunctival sac of the rabbit eye were slight to moderate reddening and slight to moderate swelling of the conjunctivae observed in all animals on administration day. From day 2 onwards slight conjunctival reddening was seen in three out of four animals until day 2, day 4 , day 6 and slight swelling was seen only in one out of four animals until day 3. Olle animal was without findings on day 2, one on day 3, one on day 5 and one on day 7.
The treatment did not result in any effect on body weight.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A combined study on acute dermal toxicity and on local tolerance was conducted . The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion. In this studya single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg was tolerated without any local irritations.
In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight irritation which was fully reversible 7 days after treatment at the latest. The calculation of mean values of the findings according to the system of evaluation recommended for the EU (1) revealed 0 for the parameter cornea and iris,0.17 for conjunctival swelling and 0.58 for conjunctival reddening.. According to EU classification criteria the test substance need not be labelled as an eye irritant.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available
Justification for selection of eye irritation endpoint:
Only one study available
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required.
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