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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Start: 25 Jul 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (test substance purity not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
test substance purity not specified; body weight gain not recorded, no data on gross pathology
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethylhexyl Palmitate
- Physical state: Liquid, colorless
- Lot/batch No.: B216
- Analytical purity: no data

Test animals

Species:
rat
Strain:
CD-1
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kent, U.K.
- Weight at study initiation: 169 - 250 g
- Housing: animals were housed in single sex groups in polypropylene cages
- Fasting period before study: overnight
- Diet: modified 41B diet, Pilsbury's Limited, Birminham, UK, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
vegetable oil
Details on oral exposure:
DOSAGE PREPARATION: The required dose level per kilogram bodyweight was suspended in vegetable oil on a weight/volume basis to a total volume of 10 mL.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animal were weighed prior to dosing. Mortality/Toxicity: immediately after dosiung, 4 h after dosing and the daily for 14 days.
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality, adverse clinical signs observed at this unique dose level
Mortality:
No mortality occured during the observation period.
Clinical signs:
No overt signs of toxicity were observed up to the end of the observation period.

Applicant's summary and conclusion

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