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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-Methyl-1,5 pentanediol
- Physical state: clear, colorless liquid
- test substance recieved on (date): 1 July 1987
- Sample designation: 3-Methyl-1,5-pentanediol
- Purity: > 99%
- Stability under test conditions: the stability and absorption of the test substance were not determined
- Storage condition of test material: at ambient temperature
- Other: the test substance was administered as supplied by the sponsor

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: three New Zealand White rabbits (from Buckmaster, Henham, Hertfordshire, England)
- Age at study initiation: approx. 9 to 10 weeks
- Weight at study initiation: approx. 2.0 to 2.3 kg prior to treatment
- Housing: individually housed in metal cages
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet
- Water (e.g. ad libitum): tap water
- Acclimation period: acclimated to the laboratory environment

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml aliquot of 3-methyl-1,5-pentanediol
Duration of treatment / exposure:
4 hr
Observation period:
Examination of the treated skin was made on day 1 (approx. 30 minutes after removal of the patches), 2, 3 and 4.
Number of animals:
3
Details on study design:
Rabbits were dosed with 0.5 ml of the test substance. The dose was applied under a 2.5 cm square gauze pad to a clipped, intact skin site of each animal. Each treatment site was occulded with "Elastoplast" elastic adhesive dressing for a four hour period. At the end of the exposure period, the semi-occulsive dressing and gauze pad were removed and the treatment site was washed using water to remove any residual test substance.

Examination of the treated skin was made on day 1 (approx. 30 minutes after removal of the patches) and on days 2, 3, and 4


Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system as follows:

Erythema and eschar formation:
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 4
in depth)

Oedema formation:
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 4
beyond the area of exposure)

Interpretation of results and classification of substance
The results obtained were evaluated taking into consideration the nature and the reversibility or irreversibility of the findings observed. Classification of the substance is based on the criteria laid down in: Regulation 1272/2008 EC, Annex I, table 3.2.2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: see Remarks
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: see Remarks
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: see Remarks
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other:
Remarks:
first reading taken approx 30 mins after removal of dressing
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: see Remarks
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: see Remarks
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other:
Remarks:
first reading taken approx 30 mins after removal of dressing
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: see Remarks
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: see Remarks
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24hr
Remarks on result:
other:
Remarks:
first reading taken approx 30 mins after removal of dressing
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: see Remarks
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: see Remarks
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Very slight erythema was observed in all three animals on Day 1. The reactions had resolved by Day 2.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions described in this study report, 3-methyl-1,5-pentanediol was considered as non-irritant when applied to the skin of rabbits.