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Diss Factsheets

Administrative data

Description of key information

Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg [Schering AG, Report No. X325 -draft-, 1998-11-05]


Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg [Schering AG, Report No. X323 -draft-, 1998-11-05]

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:
August to September 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996-03-22
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
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 mortality occurred. One male animal showed ruffled fur and atactic gait on the first day after administration of ZK 34517. The other animals were without findings over the whole study period. No compound-related findings were observed in body weight gain. At autopsy a diminished size of seminal vesicles were seen in the male animals.

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

The single oral administration of the test substance (ZK 34517) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. One male animal showed ruffled fur and atactic gait on the first day after administration of ZK 34517. The other animals were without findings over the whole study period. No compound-related findings were observed in body weight gain. At autopsy a diminished size of seminal vesicles were seen in the male animals.

The acute oral toxicity of Dimethylenketon 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 1998
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 402 (Acute Dermal Toxicity)
Version / remarks:
1987-02-24
Deviations:
yes
Remarks:
3 instead of 5 animals/sex used according to acute-toxic-class-method (OECD 423)
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 compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.

No local intolerance reactions at the application sites were observed.

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

The single dermal administration of the test substance (ZK 34517) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The acute dermal toxicity of Dimethylenketon 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 34517) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. One male animal showed ruffled fur and atactic gait on the first day after administration of ZK 34517. The other animals were without findings over the whole study period. No compound-related findings were observed in body weight gain. At autopsy a diminished size of seminal vesicles were seen in the male animals. The acute oral toxicity of Dimethylenketon in rats is therefore above 2000 mg/kg body weight.

The single dermal administration of the test substance (ZK 34517) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The acute dermal toxicity of Dimethylenketon 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.