Alcohols, C13-15-branched and linear

Endpoint summary

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

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 or test system 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

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.