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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:
December 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. The analytical purity of the substance in the test product was not reported. Instead, it was based upon the estimated ranges for the product derived from the production recipe.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
the analytical purity of the test substance is not reported
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ceraphyl 424
- Analytical purity: mixture of tetradecyl myristate, tetradecyl laurate and tetradecanol (approx. 60-30-10 %w/w)
- Received: November 13, 1975

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- 30 young albino rats, equal number of male and female rats
- Weight at study initiation: 200-300 g
- Fasting before study: yes, 24 h
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no information

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30%
- Amount of vehicle + substance: 2, 4, 6, 16, 20, 25, 32, 64 mL/kg
Doses:
0.7, 1.3, 2.0, 5.3, 6.7, 8.3, 10.7, 21 g/kg bw
No. of animals per sex per dose:
5 animals per dose, male or female, both sexes were equally distributed..
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- After dosage animals on the same dosage level were placed in a common cage with free access to food and water.
- The animals were observed daily for a two week period.
- No postmortem, or histopathology examinations were performed in this particular study.

Statistics:
LD50 calculation based on probit analysis.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
8 600 mg/kg bw
Based on:
test mat.
95% CL:
>= 7 670 - <= 9 600
Mortality:
Total dose Test material Animals Animals
exposed dead % mortality
20 6.7 5 0 0
25 8.3 5 2 40%
32 10.7 5 5 100%
64 21.3 5 5 100%
Clinical signs:
The animals dosed at 0.7-1.3 g/Kg: unkempt coats for 12-16 hours after dosing. At 2.7 g/Kg: sluggish and impaired locomotion and unkempt coats whch recovered within 48 hours. At 5.3 and 6.7 g/kg: Staggering gait and impaired locomotion accompanied with ruffled and unkempt coats. At higher doses: Loss of motor control and dirty unkempt coats were evident, coma prior to death.
Body weight:
No information available.
Gross pathology:
No information available.
Other findings:
No information available.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified