Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well detailed, but not GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
The test was done before the guideline was available
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Impurities: no data
lot/batch No: LE 5452

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Les Oncins, IFFA CREDO
- Weight at study initiation: 140 to 180 g
No more data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: On the shaved back
- % coverage: 6 x 6 cm
- Type of wrap if used: aluminium + adhesive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): soapy lukewarm tap water
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
2220, 3330, 5000, 7500 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment
Details on study design:
A preliminary test was done on 2 males and 2 females to determine the toxicity in order to choose doses for the main test.

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: every 5 days for the highest doses without mortality.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Statistics:
Calculation according to the method of Dragstedt and Lang.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 700 mg/kg bw
Based on:
test mat.
Mortality:
2200 mg/kg: 1/10 died on D1
3330 mg/kg: no mortality
5000 mg/kg: 6/10 animals died on D1
7500 mg/kg: 9/10 animals died between 2h and D1
Clinical signs:
All animals at all doses cried immediately after application.
2200 mg/kg: After 2h, piloerection, flushed limbs
3330 mg/kg: After 2h, reduced spontaneous activity, flushed limbs and ears.
5000 mg/kg: After 2h, prostration, increase of cutaneous temperature, flabby body
7500 mg/kg: After 2h, prostration, inhibition of the turning reflex , dyspnea
Body weight:
No statistical different from the control.
Gross pathology:
no
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
With a LD50 at 4700 mg/kg, o-trifluoromethylaniline is not classified according to the CLP 1272/2008/EC criteria.
Executive summary:

In an acute dermal toxicity study (IFREB n°8 03 103), groups of Sprague-Dawley rats (male/female) were dermally exposed to o-trifluoromethylaniline for 24 hours to a dorsal area of 6*6 cm, at doses of 2220, 3330, 5000 and 7500 mg/kg bw. Animals then were observed for 15 days.

Dermal LD50 Combined = 4700 mg/kg bw.

Based on the LD50 in males and females, o-trifluoromethylaniline is not classified for toxicity by dermal exposition according to the CLP 1272/2008/EC criteria.