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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
Study period:
1988-11-08 to 1988-11-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well docmented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EC Directive L251 of 1984-04-25
Principles of method if other than guideline:
4 rabbits dermally exposed to 0.5 mL of test material semi-occlusively for 4 hrs, observed for 7 d
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Nonanal, CAS No. 124-19-6
- Substance type: Fragrance material
- Physical state: Liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: In the dark at approx. 4 °C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gorseside Rabbits, Northchurch, Berkhamsted, Hertfordshire, United Kingdom
- Age at study initiation: 10-12 wks
- Weight at study initiation: approx. 2 kg
- Housing: Individually in grid-bottomed metal cages
- Diet: Commercial antibiotic-free pellet diet ad libitum
- Water: Mains water ad libitum
- Acclimation period: ≥ 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 17- 23 °C typically; dropped to 5 °C temporarily during acclimation due to heating failure
- Humidity: 37 % - 68 %
- Air changes (per hr): No data
- Photoperiod: 12 hrs dark / 12 hrs light)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Volume applied: 0.5 mL
Duration of treatment / exposure:
4 hrs
Observation period:
7 d (observations at 1 hr, 24 hrs, 48 hrs, 72 hrs, 7 d)
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm square
- Type of wrap if used: Lint held in place with "Elastoplast" elastic adhesive bandage 10 cm wide

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool in warm water.
- Time after start of exposure: 4 hrs

SCORING SYSTEM: Standard Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 349
Time point:
other: Mean of 24, 48, 72 hrs
Score:
2
Reversibility:
not reversible
Remarks:
within 7 d
Irritation parameter:
edema score
Basis:
animal: 349
Time point:
other: Mean of 24, 48, 72 hrs
Score:
1.17
Reversibility:
not reversible
Remarks:
within 7 d
Irritation parameter:
erythema score
Basis:
animal: 370
Time point:
other: Mean of 24, 48, 72 hrs
Score:
2
Reversibility:
not reversible
Remarks:
within 7 d
Irritation parameter:
edema score
Basis:
animal: 370
Time point:
other: Mean of 24, 48, 72 hrs
Score:
1.5
Reversibility:
not reversible
Remarks:
within 7 d
Irritation parameter:
erythema score
Basis:
animal: 374
Time point:
other: Mean of 24, 48, 72 hrs
Score:
2
Reversibility:
not reversible
Remarks:
within 7 d
Irritation parameter:
edema score
Basis:
animal: 374
Time point:
other: Mean of 24, 48, 72 hrs
Score:
1
Reversibility:
not reversible
Remarks:
within 7 d
Irritation parameter:
erythema score
Basis:
animal: 381
Time point:
other: Mean of 24, 48, 72 hrs
Score:
2.17
Reversibility:
not reversible
Remarks:
within 7 d
Irritation parameter:
edema score
Basis:
animal: 381
Time point:
other: Mean of 24, 48, 72 hrs
Score:
2.17
Reversibility:
not reversible
Remarks:
within 7 d
Irritant / corrosive response data:
Marked desquamation at 7 d

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was assessed for skin irritation in rabbits following a 4 hour exposure period. The results indicate that the test material was irritating to skin as the mean erythema score was 2.0 in all 4 animals which was equal to the threshold value of 2.0 under Regulation 67/548/EEC (DSD).