Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 June and 04 July 2000
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
not specified
Qualifier:
according to
Guideline:
other: EEC methods for the determination of toxiity, Annex to Directive 92/69/EEC
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report: T-7499; Perfluorobutanesulfonyl fluoride
- Physical state: Liquid/gas
- Analytical purity: 98%
- Expiration date of the lot/batch: 6 October 2000
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Highgate farm, Market Rasen, Lincolnshire, England
- Age at study initiation: at least 12 weeks of age
- Weight at study initiation: 2922 g to 3703 g
- Housing:- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +\- 2 degrees C.
- Humidity (%): 30% to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: 20 June To: 04 July 2000

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 100 mm x 100 mm
- % coverage: approx.10%
- Type of wrap if used: waterproof dressing circled around the animal trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water after the exposure period.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dose volume of 1.18 ml/kg bodyweight; 2000 mg/kg-bw/day
- Concentration (if solution): Administered as supplied
- Constant volume or concentration used: unknown; responsibility of sponsor
- For solids, paste formed: n/a
Duration of exposure:
24h
Doses:
1
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Checked twice daily for mortality and clinical signs (frequent clinical observations made soon after dosing on day 1) ; bodyweight recorded on days 1 (prior to dosing) , 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: Exposure duration = 24h
Mortality:
No mortality was observed in the study
Clinical signs:
No dermal response to treatment was observed in any animal throughout the observation period (all erythema and edema scores were 0).
Body weight:
All animals were considered to have acheived satisfactory bodyweight gains throughout the study.
Gross pathology:
No macroscopic abnormalities were observed for animals killed at study termination.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal dermal dose to rabbits of the test article was demonstrated to be greater than 2000 mg/kg bodyweight. The test article will not require labelling with the risk phrase R21 "Harmful in contact with skin," in accordance with Commission Directive 93/21/EEC.
Executive summary:

The acute dermal toxicity of the test article was tested in New Zealand White (5 female/5 male) rabbits. The rabbits received a single topical application of the test substance administered as supplied at a dosage of 2000 mg/kg bodyweight. All animals were sacrificed as scheduled at study termination (Day 15) and subjected to a macroscopic examination. There were no clinical signs of reaction to treatment, nor dermal response to treatment observed in any animal throughout the study. All animals were considered to have achieved satisfactory bodyweight gains throughout the study. No macroscopic abnormalities were observed for animals killed at study termination. The acute lethal dermal dose to rabbits of T-7499 was demonstrated to be greater than 2000 mg/kg bodyweight. The test article will not require labelling with the risk phrase R21 "Harmful in contact with skin," in accordance with Commission Directive 93/21/EEC.