Registration Dossier

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: Test conducted according to published OECD guideline 402 and to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Decane-1,2-diol
EC Number:
214-288-2
EC Name:
Decane-1,2-diol
Cas Number:
1119-86-4
Molecular formula:
C10H22O2
IUPAC Name:
decane-1,2-diol
Test material form:
other: White solid
Details on test material:
- Name of test material (as cited in study report): 1,2-Decanediol
- CAS number: 1119-86-4
- EC number: 214-288-2

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Test animal: Sprague-Dawley CD (Cr1: CD® ( SD) 1GS BR) strain
- Source: Charles River (UK) Ltd, Margate, Kent, UK.
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: At least 200g
- Housing: In suspended polypropylene cages furnished with woodflakes. The animals were housed 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): Free access to food (Rat and Mouse SQC Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK)
- Water (e.g. ad libitum): Free access to mains drinking water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 per hour
- Photoperiod (hrs dark / hrs light): Controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: solid moistened with distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: Area on back and flanks clipped free of hair
- % coverage: Approximating to 10% of the total body surface area
- Type of wrap if used: Surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: yes - moistened with distilled water

Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 of each sex
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours alter dosing and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: Skin reactions according to Draize criteria - see below -Any other skin reactions, if present were also recorded.

EVALUATION OF SKIN REACTIONS

Erythema and Eschar Formation Value:
No erythema (0)
Very slight erythema (barely perceptible) (1)
Well-defined erythema (2)
Moderate to severe erythema (3)
Severe erythema (beet redness) to slight eschar formation (injuries in depth) (4)

Oedema Formation Value:
No oedema (0)
Very slight oedema (barely perceptible) (1)
Slight oedema (edges of area well-defined by definite raising) (2)
Moderate oedema (raised approximately 1 millimetre) (3)
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) (4)

Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.



Statistics:
Not reported

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortalities
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systernic toxicity
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Skin reactions

Very slight erythema was noted at the treatment site of one male one day after dosing. No other signs of dermal irritation were noted in males.

Very slight to well-defined erythema was noted at the treatment sites all females one day after dosing with very slight erythema noted at the treatment sites of three females two days after dosing. Other skin reactions noted at the treatment sites of females were a hardened light brown coloured scab, small, superficial scattered scabs, crust formation and desquamation.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: other: EU CLP
Conclusions:
The acute dermal median lethal dose (LD50) of the test material, in the Sprague-Dawley CD (Cr1: CD® (SD) 1GS 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 EU CLP labelling regulations.
Executive summary:

The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD (Crl: CD® (SD) 1GS BR) strain rat. The method was designed to meet the requirements of the following: a) OECD Guidelines for the Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 February 1987) and b) Commission Directive 92/69/EEC Method B3 Acute Taxicity (Dermal).

A group of ten animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths. There were no signs of systemic toxicity.

In relation to the skin, very slight to well-defined erythema was noted at the treatment sites of one male and all females. Other signs of skin irritation noted at the treatment sites of females were a hardened light brown coloured scab, small superficial scattered scabs, crust Formation and desquamation.

All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy.

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Cr1: CD® (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.