Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Pre-GLP study performed similar to OECD Guideline 401 with minor deviations: no data on source of animals and environmental conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no data on source of animals and environmental conditions
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
RIFM: 71-67 (5-11-71)
Amber colored
Viscous liquid
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Used as supplied

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 118-137 g
- Fasting period before study: Overnight
- Housing: Animals were housed in groups of five males or five females in suspended stainless steel wire mesh cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
None
Doses:
5 mL/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for toxic symptoms and mortality were made at ½, 1, 2, 4 and 24 hours, and then daily for 14 days after dosing. Animals were weighed initially and at 14 days.
- Necropsy of survivors performed: Yes; gross pathological examination was performed for all animals.
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Mortality:
Only 1 male died within a 48-hour period.
Clinical signs:
Toxic symptoms consisted of slight salivation, slight ataxia, slight respiratory depression and a slight decrease in spontaneous activity started 1 hour after dosing and persisted through 4 hours. By 24 hours, all animals appeared normal except one male which was unconscious and died within 48 hours.
Body weight:
Mean body weight gains in females and males were 44 and 88 g, respectively.
Gross pathology:
No gross pathological changes were noted upon necropsy.
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 test conditions, the oral LD50 of the test substance is >5 mL/kg bw in rats. Therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the Globally Harmonised System of classification and labelling of chemicals (GHS). No signal word or hazard statement is required.
Executive summary:

In an acute oral toxicity study performed similar to the OECD Guideline 401, a single dose of 5 mL/kg bw of undiluted test substance was given by oral gavage to a group of 5 male and 5 female Sprague Dawley rats. Animals were then observed for mortality, clinical signs and body weight changes for 14 days, and were all sacrificed for macroscopic examinations.

Only 1 male died within a 48-hour period. Toxic symptoms consisted of slight salivation, slight ataxia, slight respiratory depression and a slight decrease in spontaneous activity started 1 hour after dosing and persisted through 4 hours. By 24 hours, all animals appeared normal except one male which was unconscious and died. Mean body weight gains in females and males were 44 and 88 g, respectively. No gross pathological changes were noted upon necropsy.

Rat Oral LD50 >5 mL/kg bw.

Under the test conditions, the oral LD50 of the test substance is >5 mL/kg bw in rats. Therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the Globally Harmonised System of classification and labelling of chemicals (GHS). No signal word or hazard statement is required.