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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:
From 22 to 26 July 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study run to a reliable method but not to GLP and no guideline followed

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no reading at 48 h
Principles of method if other than guideline:
Three male and three female rabbits were tested in this study, the test substance were applied to both intact and abraded skin of each animal. The patches were left in position for 24 h. The test sites were scored immediately after removed and again after 48 h to give the required 24 h and 72 h readings.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Cheshire Rabbits Farms
- Weight at study initiation: 2.5-3.0 kg
- Housing: They were housed individually in cages with a grid floor, beneath which was a peat moss filled tray.
- Diet (e.g. ad libitum): The animals were fed on Spratt's Rabbit Diet, ad libitum.
- Water (e.g. ad libitum): Water was allowed ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C (extremes of 16°C-23°C)
- Humidity (%): 64% (extremes of 60%-74%)

No additional data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: The rabbits were prepared by clipping the skin of the back and flanks of all animals free from hair and 2 of the 4 test areas on each rabbit were abraded using a 'sterilin' blood lancet.
Vehicle:
physiological saline
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

No additional data
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3 male and 3 female
Details on study design:
TEST SITE
- Area of exposure: back and flanks
- Type of wrap if used: The patches were covered by an overlapping patch of impermeable plastic adhesive tape. The whole area was then bound by Sleek occlusive tape wrapped round the entire trunk of the animal.

SCORING SYSTEM: Draize

No additional data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean of 24 and 72 hours
Score:
0.58
Max. score:
2
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean of 24 and 72 hours
Score:
0.33
Max. score:
2
Reversibility:
no data
Irritant / corrosive response data:
The test substance in physiological saline elicited very slight to well defined erythema at both abraded and non-abraded sites on 3/6 rabbits. Remaining rabbits showed no response to test substance at 24 h. At 72 h erythema persisted in one rabbit at both the abraded and non-abraded sites.
Very slight to slight oedema was noted on both abraded and non-abraded sites on 2 rabbits, the remaining animals showing no response on either site at 24 h. At 72 h very slight oedema persisted in one rabbit at the non-abraded site.
Other effects:
No information provided

Any other information on results incl. tables

 

Rabbit No./sex

Skin score

Erythema

Oedema

24 hours

1

0

0

2

2

2

3♂

1

0

4♀

0

0

5♂

0

0

6♀

2

1

72 hours

1♂

0

0

2♀

2

1

3♂

0

0

4♀

0

0

5♂

0

0

6♀

0

0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is a mild skin irritant to New Zealand White rabbit. However under the Regulatin (EC) No 1272/2008 it is not classified for skin irritation
Executive summary:

Under the Regulatin (EC) No 1272/2008 the test substance, tested as 60% w/w HMX in physiological saline, is not classified for skin irritation.As per the table below the mean score for erythema/eschar or for oedema wasn't between 2.3 and 4.0 calculated between two time points: 24 and 72 hours.

  Animal no. Erythema/Eschar
(mean score)
Oedema
(mean score)
 
  1   0   0  
24/72hrs 2   2   1.5  
  3   0.5   0  
  4   0   0  
  5   0   0  
  6   1   0.5