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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982/06/30 to 1982/08/09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions. However, little information provided in the report about the test material and how it was stored.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Federal Hazardous Substances Act 16 CFR - P.114
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): OS# 48604B

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 - 300g
- Fasting period before study: overnight
- Housing: stainless steel with elevated wire mesh floor
- Diet (e.g. ad libitum): Wayne Lab-Blox ad libitum (with-held overnight prior to dosing)
- Water (e.g. ad libitum): Tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23
- Humidity (%): 40 - 50
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 28 April 1982 To: 24 May 1982

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
dosed at 5g/kg
Doses:
2g/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Frequently on day of dosing, twice per day thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
All animals appeared ruffled after 3 hours. Diarrhea and urine staining of the genitalia was observed over the next 24 - 72 hours. The animals appeared essentially recovered after 4 days.
Gross pathology:
No treatment related effects

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the substance is > 2000 mgkg
Executive summary:

Test Guidance

Acute oral toxicity was investigated using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations.

Method and Material

A group of ten (5 male and 5 female) albino rats (Sprague-Dawley) were dosed with 2000 mg/kg of the test material by oral gavage. The animals were observed for 14 days after test material administration for signs of toxicity and mortalities. Gross autopsies were performed on all animals that either died within the 14 day observation period or on surviving animals.

Results

The test material gave an LD50> 2000 mg/kg bw. There were no mortalities. All animals appeared ruffled after 3 hours. Diarrhea and urine staining of the genitalia was observed over the next 24 - 72 hours. The animals appeared essentially recovered after 4 days.

Conclusion

The substance is not classified in accordance with CLP Regulation (EC) No 1272/2008..