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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity in the rat

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
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
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): D 25-207 (ID Code TKA 40108)

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. #06520471
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 4 days
- Observations performed: mortality, clinical signs
- 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: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute toxicity testing. Additionally, reduced locomotor activity was observed in the females. The animals recovered within 4 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 for D 25-207 in the rat was > 2000 mg/kg. No mortality occurred during the study.
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

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an exploratory study, the acute oral LD50 for D 25-207 in the rat was > 2000 mg/kg.  No mortality occurred during the study.

Justification for classification or non-classification

Based on the available data, D 25 -207 is not classified for acute oral toxicity according to Regulation (EC) No 1272/2008.