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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:
3rd to 17th December 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not conducted to a recognised guideline however methods well written and look similar to OECD 404. Conducted to GLP. Read across from analog substance.
Justification for type of information:
Category and read across justification attached in section 13 and in appendix of CSR

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
CAS 68784-26-9
EC 272-234-3

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: L.I.T. Rabbitry, Whitehall, Montana
- Age at study initiation: The animals were 17-19 weeks of age at the time of dosing.
- Housing: The animals were housed individually in wire-bottom cages in an air conditioned room.
- Diet (e.g. ad libitum): The animals were fed a daily ration of Purina Laboratory Rabbit Chow HF #5326.
- Water (e.g. ad libitum): Free access to water.
- Acclimation period: Conditioning period of nine weeks prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8-22.3°C
- Humidity (%): 18.2-62.7%
- Photoperiod (hrs dark / hrs light): The photoperiod was a 12-hour light/dark cycle: lights on at 0630 and off at 1830.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shaved and both abraded and unabraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
The test material was delivered neat.
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours, 7 and 14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: One-half milliliter of the test material was applied to each of two intact and two abraded sites on the back of each rabbit.
- Type of wrap if used: After application, each treated site was covered with a gauze patch secured in place by porous tape. The trunk of each animal was loosely wrapped in a plastic sheet, and paper toweling was wrapped around the plastic sheet to prevent tearing. A collar was also placed on each animal to protect the wrappings during the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with mineral oil and a gauze pad to remove any remaining test material.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Irritation was scored at 1, 24, 48, and 72 hours after removal of the test material and at 7 and 14 days, using the modified scoring method of Draize et al.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
1.6
Remarks on result:
other: Sum of the combined individual scores for erythema and edema at each site at 1, 24, and 72 hours divided by 72 observations.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1.6
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Intact Skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
0.9
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Intact Skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.6
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Intact Skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact Skin
Irritant / corrosive response data:
The test material caused no to well-defined erythema and edema one hour after the test material was removed. Slight to well-defined erythema was observed at 24 hours; slight edema was also seen at one treatment site. No to moderate erythema was observed 48 and 72 hours after removal of the test material. On Day 7, slight erythema was observed at four sites. Flakiness was seen at the majority of the application sites. All sites were clear of irritation on Day 14. However, one animal had flaky skin at all four application sites.There was no difference in irritation between intact and abraded sites.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The primary irritation score was 1.6.
Executive summary:

One-half milliliter of the test material was applied to two intact and two abraded areas on the back of each of six rabbits for four hours. The test material caused slight to well-defined erythema and edema through 24 hours after the test material was removed. On Days 2 and 3, slight to moderate erythema was observed. Slight erythema was observed in some animals on Day 7. All sites were clear of irritation on Day 14. The primary irritation score was 1.6.

The mean value of the scores for erythema and edema formation for 24, 48 and 72 hours was calculated to be 1 and so will not be classified as irritating according to the dangerous substances directive, 67/548/EEC.