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Diss Factsheets

Administrative data

Description of key information

Oral (Rat, OECD TG 423): LD50 > 2000 mg/kg [Schering AG, Report No. X090 -draft-, 1996-06-11]



Dermal (Rat, OECD TG 402): LD50 > 2000 mg/kg [Schering AG, Report No. X112 -draft-, 1996-09-26]

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:
December 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1981
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 animal died in the course of the study. A single i.g. application of the limit-dose was tolerated without compound-related findings. The body weight gain on days 7 and 14 was within the normal range for rats of this age and strain, with the exception of female animals showing a slight decrease in body weight gain on Day 7. No compound-related clinical findings could be detected at the end of the study on Day 14. Autopsy also revealed no compound-related findings.

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

A single oral administration of the test substance (ZK 5560) to male and female rats at the limit-dose (2000 mg/kg) was tolerated without mortalities. No compound-related clinical signs or effects on body weight gain were observed and also autopsy revealed no compound-related findings.

The acute oral toxicity of the substance 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

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:
December 1995
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)
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
Type of coverage:
occlusive
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 animal died in the course of the study. A single dermal application of the limit dose was tolerated without compound-related findings. The body weight gain on days 7 and 14 was within the normal range for rats of this age and strain. On day 14 all surviving animals were sacrificed without showing any compound-related clinical findings. Autopsy also revealed no compound-related findings.

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

A single dermal administration of the test substance (ZK 5560) to male and female rats at the limit-dose (2000 mg/kg) was tolerated without mortalities and moreover, without compound-related findings. The body weight gain on days 7 and 14 was within the normal range for rats of this age and strain. On day 14 all surviving animals were sacrificed without showing any compound-related clinical findings. Autopsy also revealed no compound-related findings. The acute dermal toxicity of the substance 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

Additional information

A single oral administration of the test substance (ZK 5560) to male and female rats at the limit-dose (2000 mg/kg) was tolerated without mortalities. No compound-related clinical signs or effects on body weight gain were observed and also autopsy revealed no compound-related findings. The acute oral toxicity of the substance in rats is therefore above 2000 mg/kg body weight.

A single dermal administration of the test substance (ZK 5560) to male and female rats at the limit-dose (2000 mg/kg) was tolerated without mortalities and moreover, without compound-related findings. The body weight gain on days 7 and 14 was within the normal range for rats of this age and strain. On day 14 all surviving animals were sacrificed without showing any compound-related clinical findings. Autopsy also revealed no compound-related findings. The acute dermal toxicity of the substance in rats is therefore above 2000 mg/kg body weight.

Justification for classification or non-classification

Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not warranted.