Methoxycyclododecane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The department of health of the government of the United Kingdom

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methoxycyclododecane

EC Number:

221-053-8

EC Name:

Methoxycyclododecane

Cas Number:

2986-54-1

Molecular formula:

C13H26O

IUPAC Name:

methoxycyclododecane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles RIver (UK) Ltd, Margate, Kent
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation:
- Fasting period before study:
- Housing: individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet: Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, Witham, Essesx, UK, ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks of each animal
- % coverage: 10%
- Type of wrap if used: surgical gauze was placed with a piece of self-adhesive bandage


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.21 mL/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths and overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: After removal of the dressings and subsequently once daily for 14 days, the test sites were examined for evidence of primary irritation and scored according to the Draize scoring system.

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 were noted until the end of the observation period.

Clinical signs:

No clinical signs of toxicity were noted during the study.

Body weight:

All animals showed expected gains in bodyweight over the study period.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Crust formation was noted in two female animals two and three days after dosing. No other signs of dermal irritation were noted. The scores for erythema and edema were 0 throughout the study period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 value of the test material in male and female rats was found to be greater than 2000 mg/kg bw. Besides, crust formation in two female animals two and three days after dosing, no other signs of dermal irritation were noted throughout the study period (scores for eryhema and edema = 0).