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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. No information on test substance composition is available. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Stamm Wistar TNO W 74
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 9 to 14 weeks old
- Weight at study initiation: average initial weight of 180 g
- Housing: Makrolon cage type III
- Diet (e.g. ad libitum): Altromin R 1324 ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1.5 °C
- Humidity (%): 60 ± 5 %
- Photoperiod (hrs dark / hrs light): artificial lighting from 7 a.m. to 7 p.m.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Volume applied: 30ml/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 per sex per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily and once on weekends and holidays
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

The substance was tested according to a method similar to the OECD guideline 401. 5 males and 5 females were administered at a dose of 5000 mg/kg bw and observed for 14 days.

No relevant clinical signs were observed in none of the animal tested. The LD50 was then greater than 5000 mg/kg bw.