Registration Dossier
Registration Dossier
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EC number: 610-201-0 | CAS number: 446292-08-6
Endpoint summary
Administrative data
Description of key information
Oral (Rat-Wistar, GLP, OECD TG 423, EU Method B. 1 tris, EPA OPPTS 870.1100): LD50 > 2000 mg/kg [Bayer AG, Report No. PH-34455, 2006-05-19]
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:
- March 2006
- 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:
- 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- purity 99.8%
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan/Winkelmann GmbH, 33178 Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Fasting period before study: 16-24 h
- Age at study initiation: 10-14 weeks
- Weight at study initiation: 165 g - 188 g
- Housing:The animals were group caged conventionally in polycarbonate cages on low dust wood granulate bedding (J. Rettenmaier & Söhne, 73494 Rosenberg, Germany).
- Diet (e.g. ad libitum): The animals received the standard diet “Provimi Kliba 3883.0.15 Maus/Ratte Haltung, Kaiseraugst Switzerland” ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days
- Method of randomisation in assigning animals to test and control groups: The random list was based on evenly distributed chance numbers by a software application.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22±2
- Humidity (%): 55±5
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- other: tap water with the aid of 2% Cremophor EL
- Doses:
- 2000 mg/kg with an administration volume of 10 ml/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: weekly; Observations: at least once per day
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test item is of low acute oral toxicity
- Executive summary:
The acute oral toxicity to female Wistar rats of Oxaphthalimid was assessed. The test compound was formulated in tap water with the aid of 2% Cremophor EL, the administration volume was 10 ml/kg body weight.
According to the OECD guideline 423 the LD50 of Oxaphthalimid in female rats is above 2000 mg/kg (LD50 cut-off 5000 mg/kg).
Reference
A dose of 2000 mg/kg was tolerated by females without mortalities, toxicological effects on body weight and body weight gain and gross pathological findings. No clinical signs were observed.
| Dose mg/kg | Toxicological result* | Occurence of signs | Time of death | Mortality (%) |
| (1st) 2000 | 0 / 0 / 3 | -- | -- | 0 |
| (2nd) 2000 | 0 / 0 / 3 | -- | -- | 0 |
* Number of animals which died spontaneously and/or were sacrificed in moribund state / Number of animals with signs of toxicity / Total number of animals used per group
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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral toxicity of Oxaphthalimid was studied in female Wistar rats. The single oral administration of 2000 mg/kg was tolerated without any mortality and compound-related clinical or macroscopic pathological signs.
Therefore, the acute oral LD50 cut-off was determined to be >= 5000 mg/kg.
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.
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