Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-805-1 | CAS number: 213077-23-7
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity in rats (comparable to OECD 401)
Acute dermal toxicity in rats (OECD 402)
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:
- 1988
- 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 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- TEST MATERIAL NAME (as stated in study report): TK 12437
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 678 - Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- three males and three females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: at least 10 days
- Observation for signs and symptoms: yes
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study
- Clinical signs:
- other: Ruffled für, dyspnea, and hunched posture were seen. Animals recovered within 10 days.
- Gross pathology:
- At autopsy, no deviations from normal morphology were found.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified by CLP Criteria
- Conclusions:
- In an exploratory study, the acute oral LD50 of TK 12437 in rats was > 2,000 mg/kg. No mortality occurred during the study.
Reference
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
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- February 24, 1987
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- TEST MATERIAL NAME (as stated in study report): TK 12437 (Trade Name: Irgastab CH 302)
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 08520495
- Expiration date of the lot/batch: July, 1996
- Purity: within the product specifications
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: in house
- Age at study initiation: young adult
- Weight at study initiation: 209 to 247 g
- Housing: individually in Macrolon cages type 3, with standardized soft wood bedding
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland); ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 + 10 %
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
The test article was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly, - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed for mortality daily, a.m. and p.m. on working days, a.m. on weekend days. Observed for signs and symptoms daily.
- Body weights: immediately before application and on days 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- Not needed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred in this study.
- Clinical signs:
- other: Piloerection was observed in males and females on the day of application. At the application site, erythema was observed in the females followed by slight necrosis. Females recovered within 14 days.
- Gross pathology:
- No deviations from normal morphology were found.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified by CLP criteria
- Conclusions:
- In a guideline (OECD 402) rat study, the acute dermal LD50 of Irgastab CH 302 was > 2,000 mg/kg. No mortality occurred during the study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
In an exploratory study, the acute oral LD50 of Irgastab CH 302 in rats was > 2,000 mg/kg.
In a guideline (OECD 402) rat study, the acute dermal LD50 of Irgastab CH 302 was > 2,000 mg/kg.
No mortality occurred during these studies.
Justification for classification or non-classification
Based on the availble data, Irgastab CH 302 is not classified for acute oral or acute dermal toxicity according to Regulation (EC) No 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
