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Diss Factsheets

Administrative data

Description of key information

Oral (Rat, GLP, equivalent to OECD TG 423): LD50 > 2000 mg/kg [Schering AG, Report -draft-, 1994-09-23]



Dermal (Rat, GLP, equivalent to OECD TG 402): LD50 > 2000 mg/kg [Schering AG, Report -draft-, 1994-10-19]

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
pre-guideline study
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Doses:
2000 mg/kg (application volume 10 ml/kg)
No. of animals per sex per dose:
3
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

No animal died in the course of the study.

No compound-related clinical findings were observed. The body weight gain observed on day 7 and day 14 was within or slightly above the normal range for rats (M+F) of the age and strain which were routinely used in the study laboratory.

No abnormalities were observed at necropsy.

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is of low oral toxicity.
Executive summary:

The single oral administration of the test substance (ZK 10882) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. No compound-related clinical signs were observed and there were no macroscopic pathological signs.


The LD50 acute oral toxicity of 6 -Chlor-Chlormethyldien in rats is therefore above 2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
Klimisch score 1

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July to August 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
3 instead of 5 animals/sex used according to acute-toxic-class-method (OECD 423)
Principles of method if other than guideline:
combined acute dermal toxicity and local irritation study
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

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 is of low acute dermal toxicity.
Executive summary:

The single dermal administration of the test substance (ZK 10882) to male and female rats at the limit dose of 2000 mg/kg was tolerated without any mortality. No compound-related findings were observed with regard to local and clinical observation, determination of body weight and necropsy examination.


The LD50 acute dermal toxicity of 6 -Chlor-Chlormethyldien in rats is therefore above 2000 mg/kg body weight.


No local intolerance reactions at the application sites were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
Klimisch score 1

Additional information

The single oral administration of the test substance (ZK 10882) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. No compound-related clinical signs were observed and there were no macroscopic pathological signs.

The acute oral toxicity of 6 -Chlor-Chlormethyldien in rats is therefore above 2000 mg/kg body weight.

The single dermal administration of the test substance (ZK 10882) to male and female rats at the limit dose of 2000 mg/kg was tolerated without any mortality. No compound-related findings were observed with regard to local and clinical observation, determination of body weight and necropsy examination.

The acute dermal toxicity of 6 -Chlor-Chlormethyldien in rats is therefore above 2000 mg/kg body weight.

No local intolerance reactions at the application sites were observed.

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.