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Registration Dossier
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EC number: 605-617-4 | CAS number: 17183-98-1
Endpoint summary
Administrative data
Description of key information
Skin irritation (Rat): not skin irritating [Schering AG, Report -drat-, 1994-10-19]
Eye irritation (Rabbit, euivalent to OECD TG 405): not eye irritating [Schering AG, Report No. X009 -draft-, 1995-07-12]
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:
- July to August 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Principles of method if other than guideline:
- combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume1.0-1.1 ml) to male and female rats; semi-occlusive exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 30-60 min after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Type of coverage:
- semiocclusive
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3/sex
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No mortalities occurred. No compound-related findings were observed with regard to local and clinical observation, determination of body weight and necropsy examination.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not cause local skin irritation.
- Executive summary:
A single dermal administration of 6 -Chlor-Chlormethyldien (ZK 10882) to male and female rats at the dose of 2000 mg/kg (corresponding to 206-228 mg ZK 10882/male animal and 196-210 mg ZK 10882/female animal) was tolerated without any mortality.
The test substance was tolerated without any local skin irritations. The mean values of findings (at 24, 48 and 72 h) were 0 for swelling, reddening and scab formation.
No compound-related findings were observed with regard to local and clinical observation, determination of body weight and necropsy examination.
Reference
Local findings:
| Test compound ZK 10882 (2000 mg/kg) | Animal number and sex | ||||||
| Location (finding) | Time-point after end of exposure | 84M | 85M | 86M | 96F | 97F | 98F |
| Reddening and scab formation | 30 -60 min* | 0 | 0 | 0 | 0 | 0 | 0 |
| 24 hours | 0 | 0 | 0 | 0 | 0 | 0 | |
| 48 hours | 0 | 0 | 0 | 0 | 0 | 0 | |
| 72 hours | 0 | 0 | 0 | 0 | 0 | 0 | |
| Individual mean values: | 0 | 0 | 0 | 0 | 0 | 0 | |
| Mean value of all animals: | 0 | ||||||
| Swellings | 30 -60 min* | 0 | 0 | 0 | 0 | 0 | 0 |
| 24 hours | 0 | 0 | 0 | 0 | 0 | 0 | |
| 48 hours | 0 | 0 | 0 | 0 | 0 | 0 | |
| 72 hours | 0 | 0 | 0 | 0 | 0 | 0 | |
| Individual mean values | 0 | 0 | 0 | 0 | 0 | 0 | |
| Mean values of all animals | 0 | ||||||
* not included in calculations of mean values
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:
- December 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Controls:
- other: left eye served as control
- Duration of treatment / exposure:
- test substance remained in the eye - eye was not rinsed
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 4 females
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.42
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to the eye.
- Executive summary:
A single administration of 6 -Chlor-Chlormethyldien (ZK 10882) into the right eye of four female rabbits with a volume of 0.1 ml/eye (corresponding to 71.5 -76.5 mg) results in slight to moderate transient reddening and swelling of the conjunctivae and the outer eye lids in all animals on administration day. Afterwards slight to moderate conjunctival reddening (in all animals) and slight swelling (in two animals) were seen up to 24 hours after application . All animals were without findings 48 hours after application.
According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea, iris, 0.17 for conjuntival swelling and 0.42 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
Reference
Results of the study:
| Irritant Effects (Score) | |||||
| Animal | 24 h | 48 h | 72 h | Mean scores | |
| 1 | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 2 | 0 | 0 | 0.67 | |
| Conjunctivae (swelling) | 1 | 0 | 0 | 0.33 | |
| 2 | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 1 | 0 | 0 | 0.33 | |
| Conjunctivae (swelling) | 1 | 0 | 0 | 0.33 | |
| 3 | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 1 | 0 | 0 | 0.33 | |
| Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |
| 4 | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctivae (reddening) | 1 | 0 | 0.33 | ||
| Conjunctivae (swelling) | 0 | 0 | 0 | 0.0 | |
On the day of administration slight to moderate transient reddening and swelling of the conjunctivae and the outer eye lids were observed in all animals. All animals were without findings after 48 hours.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The single dermal administration of 6 -Chlor-Chlormethyldien (ZK 10882) to male and female rats at the dose of 2000 mg/kg (corresponding to 206-228 mg ZK 10882/male animal and 196-210 mg ZK 10882/female animal) was tolerated without any mortality or compound-related clinical or macroscopic pathological signs.
Although the study was with respect to skin irritation / corrosion not conducted according to current guidelines and with the most sensitive species rabbit 6 -Chlor-Chlormethyldien can be regarded as not irritating to the skin since 24 h exposure to the test substance (instead of 4 h) was tolerated by 6 rats (instead of 3 animals) without any local skin reactions.
The single administration of 6 -Chlor-Chlormethyldien (ZK 10882) into the right eye of four female rabbits with a volume of 0.1 ml/eye (corresponding to 71.5 -76.5 mg) results in slight to moderate transient reddening and swelling of the conjunctivae and the outer eye lids in all animals on administration day. Afterwards slight to moderate conjunctival reddening (in all animals) and slight swelling (in two animals) were seen up to 24 hours after application . All animals were without findings 48 hours after application.
According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea, iris, 0.17 for conjuntival swelling and 0.42 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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