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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1994-02-21 to 1994-03-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
Adopted: 24 February 1987.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5-difluoroaniline
EC Number:
206-752-8
EC Name:
3,5-difluoroaniline
Cas Number:
372-39-4
Molecular formula:
C6H5F2N
IUPAC Name:
3,5-difluoroaniline
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 218 - 260 g
- Housing: Individually in metal cages with wire mesh floors
- Diet: Standard laboratory rodent diet (Biosure LAD 1), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23°C
- Humidity: 43%
- Air changes: 10 - 15 air changes per hour
- Photoperiod: 12 hours of artificial light in each 24 hours period

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: 10
- Type of wrap if used: Gauze

REMOVAL OF TEST SUBSTANCE
- Washing: Yes, with warm water (30°C to 40°C)
- Time after start of exposure: At the end of the 24 hours period

TEST MATERIAL
- Amount applied: 2.33 mL/kg bw
- Concentration: 85.71%
- Constant volume or concentration used: yes

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cages of rats were checked at least twice daily for any mortalities. Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of five hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No
Clinical signs:
other: No signs of systemic reaction to treatment was observed. However, in two males, signs of reaction were apparent and comprised of piloerection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy, decreased respiratory rate, pallor
Gross pathology:
No macroscopic abnormalities were observed for animals killed on Day 15.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information