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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1980
Reference Type:
review article or handbook
Title:
Alcohols C12-14 Cas# 80206-82-2
Author:
Iuclid 2000
Year:
2000
Bibliographic source:
European Commission - European Chemicals Bureau

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize Test
Principles of method if other than guideline:
Primary Irritation to the skin is measured by a patch-test technique on the abraded and intact skin of the rabbits, clipped free of hair. The 6 rabbits are used in abraded and intact skin tests.
Single 24-hour application to two sites each on the intact skin of 6 rabbits. After 24 hours exposure, the patches are removed and the resulting reactions are evaluated on the basis of the designated values.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C12-14
EC Number:
279-420-3
EC Name:
Alcohols, C12-14
Cas Number:
80206-82-2
Molecular formula:
C13H28O
IUPAC Name:
Alcohols, C12-14
Details on test material:
Tradename Lorol Spezial type 70 C12-14 alcohols Type AType A. 100% Linear; >90% C12/14 (C12>14), <10% C16 [range C6-C18];

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- Rabbit
- Strain: New Zealand White
- Sex: Male
- Source: Not reported
- Age: Not reported
- Weight at study initiation: Not reported
- Number of animals: 6
- Controls: No

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: none
Controls:
no
Amount / concentration applied:
- Preparation of test substance: Undiluted
- Area of exposure: Not reported.
- Occlusion: Under plaster.
- Vehicle: None
- Total volume applied: 0.5 ml
- Postexposure period: 14 days
- Removal of test substance: Not reported.
Duration of treatment / exposure:
24 hour(s
Observation period:
- Examination time points: 24, 48 and 72 hours and 4, 5, 6, 7 and 8 days after exposure
Number of animals:
6
Details on study design:
ADMINISTRATION/EXPOSURE 24 hour occluded exposure
- Preparation of test substance: Undiluted
- Area of exposure: Not reported.
- Occlusion: Under plaster.
- Vehicle: None
- Total volume applied: 0.5 ml
- Postexposure period: 14 days
- Removal of test substance: Not reported.

EXAMINATIONS
- Scoring system: Draize
- Examination time points: 24, 48 and 72 hours and 4, 5, 6, 7 and 8 days after exposure.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24+48+72 hours
Score:
1.7
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6,
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24+48+72 hours
Score:
2.3
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24+48+72 hours
Score:
2
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24+48+72 hours
Score:
1.7
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24+48+72 hours
Score:
2
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24+48+72 hours
Score:
2.3
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #1
Time point:
other: 24+48+72 hours
Score:
1
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #2
Time point:
other: 24+48+72 hours
Score:
1
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #3
Time point:
other: 24+48+72 hours
Score:
1
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #4
Time point:
other: 24+48+72 hours
Score:
1.7
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #5
Time point:
other: 24+48+72 hours
Score:
1.7
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #6
Time point:
other: 24+48+72 hours
Score:
2
Reversibility:
not fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24+48+72 hour
Score:
2
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6, the study was terminated at day 8.
Irritation parameter:
other: Oedema
Basis:
mean
Time point:
other: 24+48+72 hours
Score:
1.4
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6, the study was terminated at day 8.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours
Score:
3.6
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6, the study was terminated at day 8.
Irritant / corrosive response data:
The test material produced a primary irritation index of 3.6 at 24 hours.
Erythema: Individual 1.7, 2.3, 2.0, 1.7, 2.0, 2.3 Group mean 2.0
Oedema: Individua 1.0 ,1.0 ,1.0 , 1.7, 1.7, 2.0 Group mean 1.4
Other effects:
None reported

Applicant's summary and conclusion

Interpretation of results:
other: irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Alcohols, C12-14 is a skin irritant according to EU criteria based on a group 24+48+72 hour mean score for erythema of 2.
According to GHS criteria the test substance is mild irritant (class 3) with all individual 24+48=72 hour erythema scores between 1.7 - 2.3 (only 2/6 gave a reading of 2.3) following a 24 hour occluded application to rabbit skin.
Executive summary:

Alcohols, C12-14 is a skin irritant according to EU criteria based on a group 24+48+72 hour mean score for erythema of 2. According to GHS criteria the test substance is mild irritant (class 3) with all individual 24+48=72 hour erythema scores between 1.7 - 2.3 (only 2/6 gave a reading of 2.3) following a 24 hour occluded application to rabbit skin.