Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Female rats acclimatisation period under laboratory condition lasted four days instead of five days. This deviation did not influence the quality or integrity of the present study.
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
At the end of the exposure period the residual test item was removed using aqua ad injectionem.
Duration of exposure:
The test item was held in contact with the skin throughout a 24-hour period.
Doses:
The test item was applied at a single dose of 2000 mg/kg body weight to each animal.
No. of animals per sex per dose:
5 Male per 2000 mg/kg body weight.
5 Female per 2000 mg/kg body weight.
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: once daily
- Frequency of weighing: on day 1 (prior to the application) and on day 8 and 15
- Necropsy performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality.
Clinical signs:
The test item showed no signs of acute dermal toxicity and no signs of dermal irritation after a single dose application.
Body weight:
A slight weight loss was recorded for 4 out of 5 female animals during the first week and again a weight loss was recorded for 1 out of 5 female animals during second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded.
The male animals showed weight gain during the first and the second week of the observation period.
Gross pathology:
No specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, single dermal application of the test item TEA Trioleate to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation.
The dermal LD50 was determined to be > 2000 mg TEA Trioleate / kg body weight.
Executive summary:

LD50: > 2000 mg/kg bw

Species/strain: WISTAR Crl: WI(Han) rats

Vehicle (moistening): no vehicle used

Number of animals: 5 male and 5 female

Duration of exposure: 24 hours

Signs of systemic toxicity related to dose level used, time of onset and duration: No treatment-related effects were observed.

Effect on organs (related to dose level): No treatment-related effects were observed.

Signs of irritation: No erythema or oedema nor any other signs of irritation were observed.