Registration Dossier
Registration Dossier
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EC number: 210-838-0 | CAS number: 624-24-8
Endpoint summary
Administrative data
Description of key information
Acute toxicity: via oral route
A single oral administration of the test substance by gavage to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, clinical signs and effects on body weight gain.and gross pathological findings. Macroscopic examinations revealed a diminished size of testes, epidydimis, prostate and seminal vesicle in all male animals and ofuterus and ovaries in all female animals. According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.
Acute toxicity: via dermal route
A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.
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:
- July to August 2002
- 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)
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Solubility and stability of the test substance in the solvent/vehicle: The formulation (emulsion) was prepared freshly on treatment day and the administrations were carried out within 1 hour after formulation.
- Species:
- rat
- Strain:
- other: Shoe: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Tierzüchter Schönwalde GmbH, Schönwalde, Germany
- Age at study initiation: no data
- Weight at study initiation: 102-118 g (males); 95-104 g (females)
- Fasting period before study: approximately 18 hours
- Housing: conventional (1 animal per cade)
- Diet (ad libitum): pell. Ssniff R/M
- Water (ad libitum): demineralized, acidified water, pH 2-3
- Acclimation period: <= 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 46-62
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- other: 9 mg NaCI + 0,85 mg Myrj 53 ad 1 mL Aqua p.i.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: no clinical signs
- Gross pathology:
- A diminished size of testes, epidydimis, prostate and seminal vesicle in all male animals and of uterus and ovaries in all female animals.
- Executive summary:
A single oral administration of the test substance by gavage to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, clinical signs and effects on body weight gain.and gross pathological findings. Macroscopic examinations revealed a diminished size of testes, epidydimis, prostate and seminal vesicle in all male animals and ofuterus and ovaries in all female animals. According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- 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:
- from August 2002 to February 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- - 3 (females) and 9 (males) instead of 5 animals/sex used
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Solubility and stability of the test substance in the solvent/vehicle: The liquid original compound was used
- Species:
- rat
- Strain:
- other: Shoe: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Tierzucht Schönwald GmbH, schönwald, germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 263-328 g (males); 181-188 g (females)
- Housing: conventional; 1 animal per cage
- Diet (ad libitum): pell. Ssniff R/M
- Water (ad libitum): demineralized, acidified, pH 2-3
- Acclimation period: >= 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 54-62
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- step I (3 males 2000 mg/kg (nominal)) had to be repeated because the application volume was to low.
step II (3 males 2000 mg/kg) had to be repeated because inadvertently the application areas were not observed 48 and 72 after termination of treatment. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 (females)
9 (males) - Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: no clinical signs
- Gross pathology:
- No findings
- Executive summary:
A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.
Reference
The slight decrease in body weight in one male animal on day 7 was not considered to be compound related because it was noted in one male animal only.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity: via oral route
There is only one study avaialble.
Acute toxicity: vial inhalation route
The endpoint study record named "rel. 4 information from RTECS" in chapter 7.2.2 of the IUCLID dossier refers to a publication which is not suitable for the hazard assessment. Therefore
"No study available" was selected for the endpoint conclusion with regard to this exposure route.
Acute toxicity: via dermal route
There is only one study available.
Justification for classification or non-classification
Based on the study results a classification according to 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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