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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
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2006
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
according to guideline
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
according to guideline
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
Specific details on test material used for the study:
purity 99.8%
Details on test animals or test system and environmental conditions:
- 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.

- Temperature (°C):22±2
- Humidity (%): 55±5
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
other: tap water with the aid of 2% Cremophor EL
2000 mg/kg with an administration volume of 10 ml/kg
No. of animals per sex per dose:
Control animals:
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
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

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

Interpretation of results:
GHS criteria not met
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
> 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.