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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1 November 2000 - 15 November 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Performed according to GLP, OECD Guideline followed and no deviations reported. Read-across study therefore it is categorised as Klimisch 2 study.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other 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
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Mixture containing zinc 3,5-bis(alpha-methylbenzyl)salicylate
- Physical state: White opaque liquid
- Lot/batch No.: K300903
- Storage condition of test material: room temperature in the dark
- Other:
- Date received : 03 October 2000

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.89 to 3.01 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet (e.g. ad libitum): Free access to food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK)
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06:00 to 18:00) and 12 hours darkness

IN-LIFE DATES: From 1 November 2000 to 15 November 2000

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hour
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 mL of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- Time after start of exposure: 4 hours

SCORING SYSTEM: See attached report for scoring system.

Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.77
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
- Very slight erythema was noted at all treated skin sites at the 24-hour observation and persisted at two treated skin sites at the 48 and 72-hour observations.
- Very slight oedema was noted at one treated skin site at the 72-hour observation.
- (See Table 1 of attached report for the individual scores for erythema/eschar and oedema).
Other effects:
Moderate desquamation was noted at two treated skin sites at the 7-day observation.
- One treated skin site appeared normal at the 48-hour observation and the two remaining treated skin sites appeared normal at the 14-day observation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 1.0 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to the CLP Regulation.
Executive summary:

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and an isolated incident of very slight oedema. Moderate desquamation was also noted. One treated skin site appeared normal at the 48-hour observation and the two remaining treated skin sites appeared normal at the 14-day observation.

Conclusion: The test material produced a primary irritation index of 1.0 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant or corrosive according to the CLP Regulation.