Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Pre-OECD, pre-GLP study, somewhat similar to OECD 401, without detailed documentation, result acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Remarks:
Pre-OECD study, performed somewhat similar to OECD TG 401, reported without detailed documentation.
GLP compliance:
no
Remarks:
pre-GLP study
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not specified

Administration / exposure

Route of administration:
oral: unspecified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period: 14 days
- Frequency of observations: daily
No further experimental details provided in the report.

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Four of ten animals died, deaths were observed on day 2, 4, 6 and 7.
Clinical signs:
Enteritis and pneumonia

Applicant's summary and conclusion

Interpretation of results:
other: not classified: criteria not met
Remarks:
according to EU CLP Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
The key acute oral toxicity test (Denine, 1973) presented in this study record showed an LD50 of >5000 mg/kg bw.
Based on this key study and additional available studies presented in the Endpoint Summary, all presenting LD50's > 2000 mg/kg bw, the substance does not need to be classified for acute oral toxicity according to EU CLP Regulation (EC) No. 1272/2008 and its amendments. However, note that classification is warranted for GHS based on the additional available study from Avon (1977) presenting a LD50 of 3690 mg/kg bw, resulting in acute oral toxicity hazard Category 5 classification.
Executive summary:

Acute oral toxicity was assessed in a pre-OECD, pre-GLP study in which 10 rats were administered the substance at a dose level of 5000 mg/kg bw. Four of ten animals died, deaths were observed on day 2, 4, 6 and 7. Clinical signs included enteritis and pneumonia. The acute oral LD50 for the substance in rats was determined to be greater than 5000 mg/kg bw.