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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity (study similar to OECD TG 401): LD50 > 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
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)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Observations: mortality, clinical signs
- Necropsy of survivors performed: yes
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
3 out of 10 animals died. One animal on day 1 and two on day 2.
Clinical signs:
Clinical signs observed included diarrhea, lethargy, ptosis and piloerection.
Gross pathology:
Upon necrosy the following results were revealed: 5/10 animals were normal; 1/10 animals were cannibalized; red exudate in the nose/mouth in 1/10 animals; yellow exudate in the nose/mouth in 1/10 animals; yellow anogenital exudate in 2/10 animals; red areas in the intestines in 2/10 animals; bloated intestines in 1/10 animals; red areas in the stomach in 1/10 animals; dark liver in 3/10 animals; mottled liver in 1/10 animals; dark lungs in 2/10 animals; dark kidney in 3/10 animals.
Interpretation of results:
other: Not classified
Remarks:
According to Regulation (EC) No. 1272/2008 and its updates
Conclusions:
The acute oral toxicity test showed an LD50 > 5000 mg/kg bw
Executive summary:

In a pre-GLP acute toxicity study similar to OECD 401, 10 rats were orally exposed to 5000 mg/kg bw test substance. 3 out of 10 animals died. Clinical signs observed included diarrhea, lethargy, ptosis and piloerection. Upon necropsy the following results were revealed: 5/10 animals were normal; 1/10 animals were cannibalized; red exudate in the nose/mouth in 1/10 animals; yellow exudate in the nose/mouth in 1/10 animals; yellow anogenital exudate in 2/10 animals; red areas in the intestines in 2/10 animals; bloated intestines in 1/10 animals; red areas in the stomach in 1/10 animals; dark liver in 3/10 animals; mottled liver in 1/10 animals; dark lungs in 2/10 animals; dark kidney in 3/10 animals. Under the conditions of the test the acute oral LD50 was determined to be >5000 mg/kg bw in rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral toxicity: In a pre-GLP acute toxicity study similar to OECD 401, 10 rats were orally exposed to 5000 mg/kg bw test substance. 3 out of 10 animals died. Clinical signs observed included diarrhea, lethargy, ptosis and piloerection. Upon necropsy the following results were revealed: 5/10 animals were normal; 1/10 animals were cannibalized; red exudate in the nose/mouth in 1/10 animals; yellow exudate in the nose/mouth in 1/10 animals; yellow anogenital exudate in 2/10 animals; red areas in the intestines in 2/10 animals; bloated intestines in 1/10 animals; red areas in the stomach in 1/10 animals; dark liver in 3/10 animals; mottled liver in 1/10 animals; dark lungs in 2/10 animals; dark kidney in 3/10 animals. Under the conditions of the test the acute oral LD50 was determined to be >5000 mg/kg bw in rats.

In a supporting study (Jenner, 1964), which presents similar results as above, five Osborne-Mendel rats per sex per dose were exposed to the test substance via oral gavage. A wet posterior, coma within 1 h after exposure, rough fur and black, soft stool were observed. The LD50 was determined to be 5930 (4750 – 7420) mg/kg bw.

Acute dermal toxicity: Additional information is available from a pre-GLP acute toxicity study (Moreno, 1978) similar to OECD 402. which does not impact the C&L. A short summary is presented below. In this study 10 rabbits were dermally exposed to 5000 mg/kg bw test substance. Animals were observed for mortality and/or systemic effects. Skin irritation was recorded and gross necropsy was carried out on all animals. A limited dose of 5000 mg/kg bw was used. Clinical signs observed included ptosis in 1/10 animals on day 1. Skin irritation effects included slight redness observed in 6/10 animals, moderate redness in 3/10 animals and slight edema in 4/10 animals. Upon necropsy the following results were revealed: 7/10 animal were normal; dark areas in the lungs in 1/10 animals; dark kidney in 2/10 animals. No animals died. The acute dermal LD50 was determined to be >5000 mg/kg bw. This result does not have an impact on the classification.

Justification for classification or non-classification

Based on the available information classification and labelling for acute oral toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its amendments.