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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (6 animals used, no analytical purity of test substance reported, no experimental 48 h reading performed).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(6 animals used, no analytical purity of test substance reported, no experimental 48 h reading performed)
Qualifier:
according to
Guideline:
other: Department of Transportation Hazardous Materials Regulation, 49 C.F.R., Chapter I, Sec.173.2410 as amended in Fed. Reg. Vol. 37, No. 57, Mar 23, 1972
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
4 h
Observation period:
3 days
Reading time points: 4, 24, and 72 h (as no irritation reaction was observed)
Number of animals:
6 animals
Details on study design:
TEST SITE
- Area of exposure: Test sides located lateral to the midline of the back (approx. 10 cm apart) were selected. One of the two sites was abraded, while the other test site remained intact.
- Type of wrap if used: test site were immidediately covered with two-inch square gaute patch secured with masking tape. The trunk was then wrapped with plastic sheeting, which held the patch in place but did not retard evaporation of the test material during the four-hour exposure period.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h

SCORING SYSTEM:
Draize scoring system (only clipped skin sites considered for evaluation)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Any other information on results incl. tables

Table 1: Irritation Scores, intact skin 

Animal #

4 h

24 h

48 h*

72 h

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1

1

0

1

0

1

0

0

0

2

1

0

0

0

0

0

0

0

3

1

0

0

0

0

0

0

0

4

1

0

0

0

0

0

0

0

5

0

0

0

0

0

0

0

0

6

1

0

0

0

0

0

0

0

*no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified