Registration Dossier
Registration Dossier
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EC number: 602-890-1 | CAS number: 122731-58-2
Endpoint summary
Administrative data
Description of key information
Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg [Schering AG, Report No. X085 -draft-, 1996-05-05]
Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg [Schering AG, Report No. X111 -draft-, 1996-09-25]
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- yes
- Remarks:
- two different sexes
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: physiol. saline + Myrj 53
- 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.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is of low acute oral toxicity: LD50 > 2000 mg/kg bw
- Executive summary:
The single oral administration of the test substance (ZK 39166) 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 oral toxicity of NIP-Monoamid in rats is above 2000 mg/kg body weight.
Reference
No compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Klimisch score 2
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- November to December 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- yes
- Remarks:
- 3 instead of 5 animals/sex used according to acute-toxic-class-method
- 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
- Vehicle:
- other: bidist. water with 0.9 % NaCI and 0.085% Myrj 53
- 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.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is of low acute dermal toxicity: LD50 > 2000 mg/kg bw
- Executive summary:
The single dermal administration of the test substance (ZK 39166) 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 NIP-Monoamid in rats is above 2000 mg/kg body weight.
No local intolerance reactions at the application sites were observed.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Klimisch score 2
Additional information
The single oral administration of the test substance (ZK 39166) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality and compound-related clinical or macroscopic pathological signs. The acute oral toxicity of NIP-Monoamid in rats is above 2000 mg/kg body weight.
The single dermal administration of the test substance (ZK 39166) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality and compound-related clinical or macroscopic pathological signs. The acute dermal toxicity of NIP-Monoamid in rats is above 2000 mg/kg body weight.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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