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Administrative data

Description of key information

The test substance was a skin irritant in an OECD 404 guideline study and showed not irritating to the eyes in an OECD guideline 405 study.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): C13 - C15 - Alkohol
- Physical state: colorless liquid
- Analytical purity: 99.3% alcohols (0.5% low boiling substances, 0.2% high boiling substances)
- Composition of test material, percentage of components: 29.5% i-C13-alcohol, 33% n-C13-alcohol, 19% i-C15-alcohol, 17.8% n-C15-alcohol
- Lot/batch No.: from continuous production
- Sustance number: 88/577
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Weight at study initiation: mean(males): 3.13 kg, female: 2.82 kg
- Housing: single
- Diet: Kliba 341, 4 mm, Klingentalmuehle, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study (same housing conditions as during the study)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12


Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
15 days
Number of animals:
3 (2 males, 1 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage)


REMOVAL OF TEST SUBSTANCE
- Washing: with lutrol and lutrol/water (1:1) at the end of the exposure period


SCORING SYSTEM: according to OECD 404 / Draize
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
2.6
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: erythema score >/= 2 in 3 animals; see table below for details
Irritation parameter:
edema score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: see table below for details
Other effects:
(Severe) scale formation at 8 and 15 days after application of test substance in 3 animals.

Animal number

Evaluation Interval

Erythema

Oedema

1

2

3

4 hour

2

2

2

1

1

1

1

2

3

24 hours

3

3

2

1

0

1

1

2

3

48 hours

3

2

3

0

0

1

1

2

3

72 hours

3

1

3

0

0

1

1

2

3

8 days

1

1

2

0

0

0

1

2

3

15 days

0

0

0

0

0

0

1

2

3

ME

3.0

2.0

2.7

0.3

0.0

1.0

ME

2.6

0.4

Calculation of the mean according to 83/467/EEC criteria of July 29 th, 1983

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): C13 - C15 - Alkohol
- Physical state: colorless liquid
- Analytical purity: 99.3% alcohols (0.5% low boiling substances, 0.2% high boiling substances)
- Composition of test material, percentage of components: 29.5% i-C13-alcohol, 33% n-C13-alcohol, 19% i-C15-alcohol, 17.8% n-C15-alcohol
- Lot/batch No.: from continuous production
- Sustance number: 88/577
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach / Main, Germany
- Weight at study initiation: male: 3.2 kg; mean(females): 3.2 kg
- Housing: single
- Diet: Kliba 341, 4 mm, Klingentalmuehle, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study (same housing conditions as during the study)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
See observation period, no washing out conducted
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
SCORING SYSTEM: according to OECD 405 / Draize


Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0.2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: see table below for details
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Other effects:
Pupil contraction in one animal 24 and 48 h after application.

Animal Number

Evaluation Interval

Corneal Opacity

Area of Corneal Opacity

Iris

Conjunctivae

Red

SW

DI

1

2

3

1 hour

0

0

0

0

0

0

0

0

0

2

2

2

0

0

0

2

3

2

1

2

3

24 hours

0

0

0

0

0

0

0

0

0

1

1

0

0

0

0

0

0

0

1

2

3

48 hours

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

2

3

72 hours

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

2

3

ME

0.0

0.0

0.0

0.0

0.0

0.0

0.3            0.0

0.3            0.0

0.0            0.0

ME

0.0

0.0

0.2            0.0

Calculation of the mean according to 83/467/EEC criteria of July 29 th, 1983.

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

SKIN IRRITATION/CORROSION

An in vitro skin irritation study was performed according to OECD guideline 404. Two male and one female Vienna white rabbits received 0.5 mL of undiluted test substance on the skin (C13-C15 alcohols; 99.3%)

for 4 hours under semiocclusive conditions, after which the skin was washed with lutrol and lutrol/water (1:1). The observation period after exposure was 15 days. The mean scores (24 - 48 -72 h) graded according to Draize for erythema and edema were 2.6 and 0.4, respectively. Erythema were reversible within 15 days, edema within 24 h, 48 h or 8 days. Additionally, scale formation (in part severe) at 8 and 15 days after application of test substance in 3 animals was observed.

EYE IRRITATION

In an eye irritation study performed according to OECD guideline 405, three Vienna white rabbits received a single instillation of 0.1 mL of the undiluted test substance in the eye. No washing out of the test substance was conducted and the observation period was 72 h. Based on Draizes scores, the mean (animal 1-3) cornea, iris, conjunctivae and chemosis scores (24 – 48 – 72 h) were 0, 0, 0.2 and 0, respectively. The redness of the conjunctivae was reversible within 24 – 48 h.

Justification for classification or non-classification

Based on the available information the test substance needs to be classified as Skin Irrit. 2: H315, in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.

Based on the available information the test substance does not need to be classified for eye irritation, as in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.