Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 September 1982 - 20 October 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-like (QA signature), guideline study with limited information on individual animals
Cross-reference
Reason / purpose:
reference to other study

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: 16 CFR 1500.3 Federal Hazardous Substances Act Regulations.
Deviations:
no
GLP compliance:
yes
Remarks:
GLP-like (QA signature)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data available.
- Age at study initiation: No data available.
- Weight at study initiation: average weight between 200~300 g.
- Fasting period before study: Feed (not water) was withheld overnight prior to dosing.
- Housing: The animals were housed and maintained in accordance with the Animal Welfare Act 9 CFR Part Stainless steel with elevated wire mesh flooring; 3 - 5 rats/cage by sex
- Diet: Wayne Lab-Blox ad libitum.
- Water: Tap water ad libitum
- Acclimation period: acclimated to the laboratory for an appropriate time prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 ± 2°F (22°C)
- Humidity (%): 45 ± 5%
- Air changes: controlled environment, but no air change information provided.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 1982-09- 10 To: 1982 -09-24

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Not applicable
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable

MAXIMUM DOSE VOLUME APPLIED: No data. Volume seleted to deliver dose of 5000 mg/kg bw

DOSAGE PREPARATION (if unusual): Not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not applicable
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed frequently on the day of dosage and twice daily thereafter (morning and afternoon). Individual weights were recorded on the day of dosage, weekly thereafter and prior to sacrifice.
- Necropsy of survivors performed: gross necropsies were performed on all animals that either died during the 14 day observation period or on surviving animals that were sacrificed at the conclusion of the 14 day observation period.
Statistics:
No data available

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities
Clinical signs:
The animals had ruffled fur after 3 hours. They appeared normal within 24 hours and throughout the remainder of the observation period.
Body weight:
All animals showed bodyweight gain.
Gross pathology:
No gross abnormalities were noted in all animals.

Any other information on results incl. tables

Table 1. Results

Dose Level (mg/kg)

5000

Sex

Male

Female

Average Body Weight (g)

Initial

243

218

7 d

298

248

14 d

344

243

Mortality (No. death/No. dosed)

0/5

0/5

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article, when administered as received to male/female Sprague-Dawley rats, had an acute oral LD50 of greater than 5000 mg/kg bodyweight
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 5000 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

There were no mortalities or signs of clinical toxicity. The acute oral LD50 in male and female rats is >5000 mg/kg bw.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for acute oral toxicity