Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 26 jun 1985 to 24 feb 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to the standardised method and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: according to EU directive 79/831 and according to OECD guideline
Deviations:
yes
Remarks:
surface area application is not mentionned in the report
GLP compliance:
yes
Test type:
other: limit test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS:
- Species: COMMON SPECIES: rat
- Strain: RAT STRAINS: Sprague-Dawley
- Sex: male/female
- Source: IFFA Credo (69510 St Germain sur l'Arbresle)
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 170-200 g (male), 150-180 g (female)
- Fasting period before study: no data
- Housing : individually. Stainless steel cage: 171*126*70 mm
- Food consumption: UAR entretien A04, ad libitum
- Water consumption:ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/-3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 10 removes
- Photoperiod (hrs dark / hrs light): no data

In-life dates: not specified

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: lateral-dorsal
- Type of wrap if used: perfored adhesive tape on gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.54 ml/kg
- Concentration (if solution): substance as it is
- Constant volume or concentration used: yes

VEHICLE: none
Duration of exposure:
24 hours
Doses:
0, 2002 mg/kg
No. of animals per sex per dose:
5
Control animals:
other: yes, distilled water
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Behaviour and mortality: at 1, 2 and 4 hours after exposure and then daily until day 14.
- weighing: at day 1, 2, 8 and 15 and then when animals died.
- Dermal observation: at day 2 and then daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ examination/

Statistics:
none

Results and discussion

Preliminary study:
Doses tested: 1001 and 2002 mg/kg on 4 animals per group (2 males and 2 females). No mortality observed.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 002 mg/kg bw
Remarks on result:
other: no mortality observed at high dose tested during preliminary study with 4 animals of both sexes, and 10% of females died at this dose in the main study.
Mortality:
1 death :1 female on day 5 at 2002 mg/kg
Clinical signs:
Ataxia, hypothermia, watering of the eyes in some animals, paleness of circulatory system, prostration
No cutaneous lesions at application site
Body weight:
Comparable as control group
Gross pathology:
On dead animal: lungs and intestines brown, brown and sticky liquid in bladder, depigmentation of liver
On sacrified animals: kidneys and/or spleen with dark colour, on 5 males and on 4 females.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not classified for acute toxicity by dermal route.
Executive summary:

In an acute dermal toxicity study (Hazleton, 1986), groups of young adult Sprague-Dawley rats males and females (5/sex) were dermally exposed to p-trifluoromethylaniline (>=98.5%) for 24 hours to lateral-dorsal at doses of  0, 2002 mg/kg mg/kg bw.  Animals then were observed for 14 days.
 
Dermal LD50 Males = >2002 mg/kg bw
      Females = >2002 mg/kg bw
      Combined = >2002 mg/kg bw
P-trifluoromethylaniline is not classified based on the LD50, according to EU criteria (67/548/EC directive) and CLP criteria.