3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

study performed between 2000-08-30 and 2000-09-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP test according to OECD test guideline

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)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran

EC Number:

251-090-5

EC Name:

3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran

Cas Number:

32539-83-6

Molecular formula:

C15H26O1

IUPAC Name:

2H,3H,4H,5H,6H,7H,8H,9H,10H,11H,12H,13H,14H-cyclododeca[b]pyran

Details on test material:

- Name of test material (as cited in study report): HR 00/690946
- Substance type: active substance
- Physical state: viscous liquid
- Lot/batch No.: 2071406
- Storage condition of test material: approximately 4°C in the dark
- Other: extremely pale yellow slightly viscous liquid

Test animals

Species:

rat

Strain:

other: SpragueDawley CD (Crl: CD° (SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Lfd, Margate, Kent, UK
- Age at study initiation: eight weeks
- Weight at study initiation: males 210-240g, females 204-220g
- Housing: suspended polypropylene cages furnished with woodflakes - individually during the 24-hour exposure period and in groups of five, by
sex, for the remainder of the study
- Diet (e.g. ad libitum): (Rat and Mouse SQC Expanded Diet No 1, Special Diets Services Limited, Witham, Essex, UK - AD LIBITUM
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
Other: The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): twelve hours / twelve hours (06:00 to 18:00)


IN-LIFE DATES: From: 2000-30-08 To: 2000-09-13

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: shorn skin
- % coverage: 10% of the total body surface area
- Type of wrap if used: surgical gauze placed over the treatment area and semi-occluded with a piece of selfadhesive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with cotton wool moistened with distilled water
- Time after start of exposure: 24h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.06 ml/kg
- Constant volume or concentration used: concentration was constant

Duration of exposure:

24 hours

Doses:

2.06 ml/kg

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Mortality:

no deaths

Clinical signs:

other: No signs of systemic toxicity

Gross pathology:

-

Other findings:

- Histopathology: No signs of dermal irritation were noted during the study.
- Other observations: necropsy: No abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: other: Commission Directive 93/21/EEC

Conclusions:

The acute dermal median lethal dose (LD50) of the test material, in the Sprague-Dawley CD (Crl:CD(R) (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

The acute dermal toxicity of test material was tested according to OECD Guideline 402 and 92/69/EEC Method B.3 Acute Toxocity (Dermal).

The acute dermal median lethal dose (LD50) of the test material, in the Sprague-Dawley CD (Crl:CD(R) (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.

The test material does not meet the criteria for classification and will NOT require labelling for dermal toxicity in accordance with DSD 67/548/EEC and CLP 1272/08/EEC.