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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: GLP-Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Ethylhexyl benzoate
- Physical state: clear colourless liquid
- Analytical purity: 99.734%
- Impurities (identity and concentrations): 2-Ethyl-4-methyl-1-pentyl benzoate 0.209%, C8 benzoate 0.023%, 2-Ethylhexyl phthalate 0.004%, unknown impurities 0.03%
- Lot/batch No.: 9915-133-2
- Expiration date of the lot/batch: 2000-12-04
- Storage condition of test material: room temperature in light, in brown glass bottle

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd. (Bicester, UK)
- Age at study initiation: at least 12 weeks
- Weight at study initiation: 2.6-2.7 kg
- Housing: animals were housed individually in stainless steel cages with perforated floors.
- Diet: Special Diet Services STANRAB (P) SQC pellet, ad libitum. The animals were fed hay on arrival and subsequently three times a week.
- Water: drinking water, ad libitum
- Acclimation period: 8 days
- Other: During the acclimatisation and study period the animals were given small soft white untreated wood blocks for environmental enrichment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-24.5
- Humidity (%): < 20-35
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:
4 h
Observation period:
14 days
Reading time points: 20 min, 16, 43 and 72 h and daily through Day 14
Number of animals:
1 male and 2 females
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: The treatment site was covered with Elastoplast elastic adhesive dressing (patch).

REMOVAL OF TEST SUBSTANCE
- Washing: The treatment site was washed with warm water to remove any residual test substance and blotted dry with absorbent paper.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 16, 43 and 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 13 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 16, 43 and 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 16, 43 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: slight erythema were still apparent
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 16, 43 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Very slight to well defined erythema was seen in all animals (mean score over 16, 43 and 72 h out of all 3 animals: 0.67). In addition, thickening of the skin was observed in two animals. Reactions gradually reversed and had resolved completely in two animals by Day 8 or Day 13, respectively. However, very slight erythema was still evident in one animal at Day 14.
Other effects:
No signs of toxicity or ill health were observed in any animal during the study period.

Any other information on results incl. tables

Table 1. Results of skin irritation study.

Observation time

Rabbit no.

1

2

3

Erythema

Edema

Erythema

Edema

Erythema

Edema

0.33 h

0

0

0

0

1

1

16 h

0

0

0

0

1

0

43 h

0*

0

1

0

1

0

72 h

2*

0

1

0

2*

0

Mean value 16 + 43 + 72 h

0.00

0.00

0.67

0.00

1.33

0.00

Mean value 16 + 43 + 72 h all animals

0.67

0.00

 

 

 

 

*: Thickening of the skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified