(S)-7-hydroxy-3,7-dimethyloctanal

Endpoint summary

Description of key information

Irritation/corrosion:
- skin: not irritating 
- eye: irritating 

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

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

not specified

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): 100%

Duration of treatment / exposure:

4 h

Observation period:

1h, 1d, 2d, 3d, 7d

Number of animals:

4

Details on study design:

SCORING SYSTEM:
Irritation was assessed and allocated a numerical value based on the following:
- 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 in depth) = 4.

- 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 mm) = 3;
Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal: all animals

Time point:

24/48/72 h

Score:

0.92

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.11

Max. score:

2

Reversibility:

fully reversible within: 7 d

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.08

Max. score:

1

Reversibility:

fully reversible within: 7 d

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was not qualified as irritating nor corrive according to the OECD TG 404.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles, not according to current guidelines

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

Internal BASF method was used

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male 3.19 kg, female 3.44 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: NaCl into other eye of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): 100%

Duration of treatment / exposure:

continuously

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

SCORING SYSTEM:
Gradings for corneal opacity, conjunctival redness and chemosis were converted into numerical grading system acc. to Draize.

Chemosis (Swelling) and cornea (Opacity):
0 = none
1 = slight
2 = well defined
3 = severe
4 = very severe


Conjunctival redness (Redness):
0 = normal
1 = slight
2 = well defined
3 = severe
4= very severe

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 72 h

Score:

1.25

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

probability of weak irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

other: 24, 72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: not specified for 48h

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: not specified for 48h

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: not specified for 48h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: not specified for 48h

Animal 1: male

Animal 2: female

Results:

Readings	Animal	Erythema	chemosis	Corneal opacity	Additional findings
1h	1	2	1	1	miosis
	2	2	3	2	miosis
3 h	1	2	1	1	discharge
	2	2	2	2	discharge
24 h	1	1	1	2	mucosal hemorrhages
	2	2	1	2	mucosal hemorrhages
72 h	1	1	0	1	mucosal hemorrhages
	2	1	0	3	mucosal hemorrhages, scar
4 d	1	1	0	1	mucosal hemorrhages
	2	1	0	3	mucosal hemorrhages, scar
7 d	1	1	0	1
	2	1	0	1	scar
8 d	1	1	0	1
	2	1	0	1	scar
Mean 24 - 72 h	1	1	0.5	1.5
	2	1.5	0.5	2.5
Mean		1.25	0.5	2

No effects reported for iris.

No effects observed for eyes treated with NaCl.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

In the study for eye irritation of the test item applied to eyes of two Vienna White rabbits, reactions were evaluated for eight days. As result, mean scores (24, 72 hours) for corneal opacity, conjunctival redness and chemosis were 1.5, 1 and 0.5, for animal 1 and 2.5, 1.5 and 0.5 for animal 2, respectively. Conjunctival redness and corneal opacity were not reversible within the eight day observation period. The test substance has been found to be irritating to eyes under the chosen testing conditions.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Justification for classification or non-classification

The present data on skin irritation do not fulfill the criteria laid down in CLP regulation, and therefore, the substance is not classified.

The present data on eye irritation fulfills the criteria laid down in CLP regulation.

Therefore, the substance can be classified as "irritating to eye" or "eye irritant" (category 2).