1,1,2,2,3,3,4-heptafluorocyclopentane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1997-09-03 to 1997-09-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

OJ No. L383A, 29.12.92

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

430-710-1

EC Name:

-

Cas Number:

15290-77-4

Molecular formula:

C5H3F7

IUPAC Name:

1,1,2,2,3,3,4-heptafluorocyclopentane

Specific details on test material used for the study:

Batch No.: 9705-2A
Purity: 98.18%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: selected from a stock supply of healthy male and female CD rats of Sprague-Dawley origin (Hsd: Sprague-Dawley(CD)) which were obtained from Harlan UK Ltd, Bicester, Oxon, England.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately seven to eight weeks
- Weight at study initiation: 200 to 247 g
- Fasting period before study:
- Housing: Housed individually in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet), ad libitum
- Water: ad libitum
- Acclimation period: at least six days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23
- Humidity (%): 38-65
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24-hour period.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 50 mm x 50 mm
- Type of wrap if used: The treatment area was covered with porous gauze held in place with a non irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing: At the end of exposure period the dressings was carefully removed and the treated area of skin was washed with warm water (30 to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 1.231 mL/kg bodyweight

Duration of exposure:

24 hours

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

five males and five females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Mortality: at least twice daily
- Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1, once in the morning and again at the end of experimental day for subsequent days (with the exception of Day 15 - morning only).
- Dermal responses: assessed daily
- Bodyweight: recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes, All animals were killed on Day 15 by cervical dislocation and subjected to a macroscopic exanimation which consisted of opening the abdominal and thoracic cavities.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths

Clinical signs:

no signs of systemic reaction to treatment observed

Body weight:

A slightly low bodyweight gain was recorded for one female on Day 8. All other rats were considered to have achieved satisfactory bodyweight gains throughout the study.

Gross pathology:

No abnormalities were recorded

Other findings:

- Dermal Reactions:
Transient slight dermal irritation (Grade 1 erythema only) was seen in two animals on removal of the dressings, and resolving in both instances by Day 4. In addition desquamation (characterised by localised spots/scabbing) was observed in one of these rats from Day 7 through Day 11. No dermal response to treatment was recorded for the remaining eight rats throughout the study.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute lethal dermal dose (LC50) to rats of test item was demonstrated to be greater than 2000 mg/kg bodyweight.

Executive summary:

A study was performed to assess the acute dermal toxicity of test item to the rat following ECB.3.

A group of ten rats (five males and five females) received a single dose by topical application of the test substance administered, as supplied, at a dose level of 2000 mg/kg bodyweight. All animals were kill and examined macroscopically on Day 15, the end of the observation period.

There were no deaths and no signs of systemic reaction to treatment observed throughout the study.

Transient slight dermal irritation (Grade 1 erythema only) was seen in two animals on removal of the dressings, and resolving in both instances by Day 4. In addition desquamation (characterised by localised spots/scabbing) was observed in one of these rats from Day 7 through Day 11. No dermal response to treatment was recorded for the remaining eight rats throughout the study.

A slightly low bodyweight gain was recorded for one female on Day 8. All other rats were considered to have achieved satisfactory bodyweight gains throughout the study.

No abnormalities were recorded at the macroscopic examination on Day 15.

The acute lethal dermal dose (LC50) to rats of test item was demonstrated to be greater than 2000 mg/kg bodyweight.