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Toxicological information

Skin irritation / corrosion

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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:
other: Acceptable report performed according to current guidelines

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985
Reference Type:
publication
Title:
Skin irritation and Corrosion: Reference Chemicals Data Bank
Author:
European Centre for Ecotoxicology and Toxicology of Chemicals
Year:
1995
Bibliographic source:
ECETOC Technical Report No. 66, p78

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hydroxycitronellal; 592350.1; 96/8503
- Analytical purity: 98.7% (taken from the cited publication)
no further data given

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A. Smith, 7 Kydcomb Road, Warlingham, Surrey
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18-22
- Humidity (%):42-65
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped, intact
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:
1, 24, 48, 72 h; 7 d
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: placed evenly over a 2.5 cm square of surgical lint B.P placed onto a 6 cm square area of clipped, intact dorsal skin. The lint patches were held in place by encircling the trunk of the animals with a length of 'Elastoplast' elastic adhesive bandage 10 cm wide.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with warm water
- Time after start of exposure: 4 h


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:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 7 d

Any other information on results incl. tables

Readings Animal Erythema Edema Further findings
1h 1 1 0 slight yellow staining
2 0 0 -
3 0 0 -
4 1 0 -
24h 1 2 1 -
2 0 0 -
3 1 0 -
4 1 0 -
48h 1 2 0 -
2 0 0 -
3 1 0 -
4 1 0 -
72h 1 1 0 -
2 0 0 -
3 0 0 -
4 1 0 -
7d 1 0 0 -
2 0 0 -
3 0 0 very slight desquamation
4 0 0 -
Mean (24h-72h) 1 1.7 0.3  
2 0 0  
3 0.7 0  
4 1 0  
Mean (24h-72h) all animals 0.8 0.1  

Applicant's summary and conclusion