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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Performed in accordance with published test guidelines (OECD404 and EU B.4) and in accordance with GLP.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.0- 3.5 kg
- Housing: The animals were individually housed in suspended metal cages
- Diet (e.g. ad libitum): Free access to food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK)
- Water (e.g. ad libitum): Free access to mains drinking water a
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 per hour
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): in 0.5mL of water (i.e. 1g/mL)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution): 1g/mL
Duration of treatment / exposure:
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: Dorsal flank area
- Type of wrap if used: elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4

SCORING SYSTEM: The test material was classified according to Draize (1959) Dermal Toxicity. In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p. 47.

The test sites were scored according to the following scale:

ERYTHEMA AND ESCHAR FORMATION
- No erythema (0)
- Very slight eryhthema (barely perceptible) (1)
- Well defined eryhtema (2)
- Moderate to severe erythema (3)
- Severe eryhthema (beet redness) to slight eschar formation (injuries in depth) (4)

OEDEMA FORMATION
- No oedema (0)
-Very slight oedema (1)
- Slight oedema (edges of area well-defined by definite raising) (2)
- Moderate oedema (raised approximately 1 millimetre) (3)
- Severe oedema (raised maore than 1 millimetre and extending beyond the area of exposure (4)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
Total score 19 giving average over 6 readings of 3.2
Basis:
mean
Time point:
other: average of all scores after 24 and 72hours
Score:
ca. 3.2
Reversibility:
fully reversible
Remarks:
14 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
values for rabbit 127 male
Time point:
other: mean of values at 24, 48 and 72 hours
Score:
ca. 1.33
Max. score:
2
Reversibility:
fully reversible within: 14
Remarks on result:
other: values at the 3 time points were 2, 1, and 1
Irritation parameter:
erythema score
Basis:
mean
Remarks:
values for rabbit no 122 male
Time point:
other: mean of values at 24, 48 and 72 hours
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: values at each of the 3 time points were 2, 2, and 2
Irritation parameter:
erythema score
Basis:
mean
Remarks:
values for rabbit no 125 male
Time point:
other: mean of values at 24, 48 and 72 hours
Score:
ca. 1.33
Max. score:
2
Reversibility:
not fully reversible within: 14days
Remarks on result:
other: values at the2 time points were 2, 1, and 1
Irritation parameter:
edema score
Basis:
mean
Remarks:
values for rabbit no127 male
Time point:
other: mean of values at 24, 48 and 72 hours
Score:
ca. 1.33
Max. score:
1
Reversibility:
fully reversible within: 7days
Remarks on result:
other: values at the 3 time points were 2, 1, and 1
Irritation parameter:
edema score
Basis:
mean
Remarks:
value for rabbit no 122 male
Time point:
other: mean of values at 24, 48 and 72 hours
Score:
ca. 2
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: values at the three time points were 2,2 and 2
Irritation parameter:
edema score
Basis:
mean
Remarks:
value for rabbit no 125 male
Time point:
other: mean of values at 24, 48 and 72 hours
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: values at three time points were 1, 1, and 1
Irritant / corrosive response data:
Well-defined erythema was noted at all treated skin sites one hour after patch removal and at the 24-hour observation. Well-defined erythema persisted at one treated skin site with very slight erythema at two treated skin sites at the 48 and 72-hour observations.
Slight oedema was noted at all treated skin sites one hour after patch removal with very slight to slight oedema at the 24, 48 and 72-hour observations.
Loss of skin elasticity was noted at one treated skin site at the 48 and 72-hour observations. Crust formation was noted at one treated skin site with slight desquamation at two treated skin sites at the 7-day observation.
Treated skin sites appeared normal at the 14-day observation.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize PDII classification
Conclusions:
While some degree of irritation was observed, particularly in one animal, the degree of erythema an oedema was not of sufficient magnitude (mean values of <2) to warrant classification as a Skin Irritant Category 2 under CLP Regulation (EC) No. 1272/2008.

The relevant criteria which were NOT MET were
Mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal

Executive summary:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following: a) OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion- (adopted 17 July 1992) b) Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation). No corrosive effects were noted. However, a single 4-hour, semi-occlusive application of the test material to the intact skin of three rabbits produced well-defined erythema and slight oedema. Loss of skin elasticity, crust formation and slight desquamation were also noted.

Treated skin sites appeared normal at the 14-day observation.

Based on these data a primary irritation index of 3.2 was calculated and this classifies the test substance as a moderate irritant to rabbit skin according to the Draize classification scheme. However, in the three animals tested, the test material did not demonstrate a sufficient degree of erythema or oedema to warrant classification as a Category 2 Skin Irritant (i.e. mean values were all <2), and so is considered to be non-irritating under CLP Regulation (EC) No. 1272/2008 (Version 4.1, 2015).