1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03-AUG-2017 to 15-JAN-2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Temperature values and relative humidity values outside the expected ranges were recorded during the study. These deviations have no presumed impact on the outcome or integrity of the study

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

Temperature values and relative humidity values outside the expected ranges were recorded during the study. These deviations have no presumed impact on the outcome or integrity of the study

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane

EC Number:

206-788-4

EC Name:

1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane

Cas Number:

375-50-8

Molecular formula:

C4F8I2

IUPAC Name:

1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane

Test material form:

liquid

Details on test material:

- Identifier: Diiodoperfluorobutane
- Batch: BLT 03-2017
- Expiration date: March 2022
- Purity test date: 10 March 2017
- Organic impurities: 0.3% w/w

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BLT 03-2017
- Expiration date of the lot/batch: March 2022
- Purity test date: 10 March 2017

Test animals

Species:

rat

Strain:

Wistar

Remarks:

CRL:(WI)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adults
- Weight at study initiation: 218 to 242g
- Fasting period before study: no
- Housing: Individual caging in Type II. polypropylene/polycarbonate cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 - 28.7 °C
- Humidity (%): 32 - 75 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

IN-LIFE DATES: From: 08-AUG-2017 To: 22-AUG-2017

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: approximately 10 % area of the total body surface
- Type of wrap if used: gauze pad maintained with adhesive hypoallergenic plaster. The entire trunk of the animals was then wrapped with semi occlusive plastic wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water at body temperature
- Time after start of exposure: 24 hrs

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> Clinical observations were performed on the day of treatment at 1 and 5 hours after application of the test item and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
> The body weights were recorded on Day 0 (before test item administration) and on Days 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

No clinical signs were observed after treatment with the test item or during the 14-day observation period.
No local dermal signs were observed after treatment with the test item during the 14-day observation period.

Body weight:

No effects were observed on body weights or body weight gains in any animal during the study.

Gross pathology:

No specific observations at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test item 1,4-Diiodoperfluorobutane was found to be higher than 2000 mg/kg bw in male and female Wistar rats.

Executive summary:

The acute dermal toxicity of 1,4-Diiodoperfluorobutane was investigated in CRL:(WI) rats, in compliance with OECD Guideline No.: 402.

A limit test was carried out at 2000 mg/kg body weight in both sexes (5 rats/sex). The test item was applied as supplied as a single dermal 24-hour exposure under a semi-occlusive dressing, followed by a 14-day observation period.

Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Gross macroscopic examination performed on all animals at the end of the 2-week observation period (Day 14).

There was no mortality during the study. No clinical signs and no local dermal signs were observed after treatment with the test item or during the 14-day observation period. No effects were observed on body weights or body weight gains in any animal during the study. There was no evidence of abnormalities at necropsy.

 

The acute dermal median lethal dose (LD50) of the test item 1,4-Diiodoperfluorobutane was found to be higher than 2000 mg/kg bw in male and female Wistar rats.