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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:
1986-10-06 to 1987-01-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment. Restrictions based on combined study report format and lack of detail.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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): [CAS Number 171171-80-5]
- Physical state: Dark brown viscous liquid
- Lot/batch No.: XSA 053J
- Storage condition of test material: In the dark at ambient temperature
- Stability under test conditions: Infra-red spectra taken on 14 August 1986 and 18 December 1986 showed no differences and the substance was judged to have been stable for the duration of the study

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sittingbourne Research Centre Breeding Unit
- Age at study initiation: 4-9 months
- Weight at study initiation: 3772-4160 g (males) and 3280-4142 g (females)
- Housing: Singly in hanging, stainless steel cages with all-mesh floors and tops and half-mesh fronts; each cage measuring 67 cm x 43 cm x 45 cm. The cages were mounted in three rows of two on a single-sided rack (a total of six cages).
- Diet: Standard Rabbit Diet, SQC, Special Diet Services Ltd, Essex) ad libitum by means of a top loading food hopper
- Water: Filtered but untreated water from the public supply ad libitum by means of an automatic valve-regulated drinking line
- Acclimation period: = 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature: 16-19 degrees Centigrade
- Photoperiod: Automatically controlled cycle of light (06:00 to 18:00) and dark (18:00 to 06:00)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
Single dose
Observation period:
14 days
Number of animals:
Three males and three females
Details on study design:
Each animal was identified by means of a numbered metal ear tag and/or a number written on the pinna. Dorsal hair between the shoulders and hindquarters was closely shorn with fine electric clippers. A test site was selected and a 2 cm x 2 cm lint patch containing 0.5 mL of the test substance applied to it. The patch and surrounding skin were covered by a single layer of gauze held in place by an elastic adhesive bandage.

After 4 hours, the wrapping and the patch were removed and the test site washed with water and gently dried. The site was examined and scored for erythema and oedema on a graded scale of zero to 4 using the criteria attached. Observations were made at 30 min after removal of the patch (approximately 4 h after application) and at 24, 48 and 72 h, 7 d and 14 d after patch removal. The mean score of each rabbit at each observation time was calculated together with the group mean 24, 48 and 72 h scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
1.8
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 14 d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 14 d
Score:
0
Max. score:
4
Irritant / corrosive response data:
Although there was no skin response at 4 h, all rabbits had developed minimal erythema by 24 h. The degree of irritation progressively increased up to 72 h post-dosing when all rabbits slight to moderate inflammation of the treated site. The erythema had cleared by 7 d. At 7d the oedema had subsided leaving the site very slightly reddened and the skin dry and flaky.

Any other information on results incl. tables

Primary irritation of semi-occluded rabbit skin after a single dose of the test material is described in Table 3 (attached).

Applicant's summary and conclusion

Conclusions:
The test material caused minimal erythema at 24 h progressing to moderate inflammation by 72 h post dosing. All these effects cleared within 14 days.