Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Basic data given, but considered sufficiently reliable for the purpose of hazard assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
no guideline available
Principles of method if other than guideline:
Standard acute method
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Test item: Compound No. 72-8-48
- Source of test material: Research Institute for Fragrance Materials, Inc., USA.
- Physical state: Clear liquid
- Date of receipt: 06 April 1972

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200-250 g
- Fasting period during the study: Animals were fasted for a minimum of 16 h prior to administration of the test item.
- Diet: Food, ad libitum
- Water: Water, ad libitum

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
- Test substance was administered as a concentrate.
Doses:
4000, 5000, 6250 and 7800 mg/kg bw
No. of animals per sex per dose:
10 males/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality were made at 1 and 6 h after dosing and daily thereafter for 14 days.
- Necropsy of survivors performed: Yes; all surviving animals were sacrificed for gross necropsy examination.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
5 600 mg/kg bw
Based on:
test mat.
95% CL:
5 000 - 6 200
Mortality:
- Deaths occurred overnight following administration of test substance.
- 1/10, 4/10, 7/10 and 10/10 animals were died at 4000, 5000, 6250 and 7800 mg/kg bw, respectively.
Clinical signs:
Rats experienced lethargy, diarrhea and urinary incontinence.
Body weight:
No data
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Executive summary:

In an acute oral toxicity study, groups (10 males/dose) of Wistar rats were given a single oral dose of test substance at 4000, 5000, 6250 and 7800 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and all survivors were sacrificed for macroscopic examination.

 

Rats experienced lethargy, diarrhea and urinary incontinence. Deaths occurred overnight following administration of test substance. 1/10, 4/10, 7/10 and 10/10 animals were died at 4000, 5000, 6250 and 7800 mg/kg bw, respectively. In this study, the oral LD50 of test substance was 5600 mg/kg bw with 95 % confidence limits of 5000-6200 mg/kg bw in male rats.

 

Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.