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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
See attached justification in section 13.2
Reason / purpose for cross-reference:
read-across source
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.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2019
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
7-hydroxycitronellal
EC Number:
203-518-7
EC Name:
7-hydroxycitronellal
Cas Number:
107-75-5
Molecular formula:
C10H20O2
IUPAC Name:
7-hydroxy-3,7-dimethyloctanal

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
not specified

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was not qualified as irritating nor corrive according to the OECD TG 404.