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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of federal regulations, Title 16, Section 1500.41 (USA)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): methyl tetrahydrophthalic anhydride (grade A)(HN-2200)
- Lot/batch No.: 1852
- Molecular formula (if other than submission substance): C9 H10 O3
- Molecular weight (if other than submission substance): 166.18
- Smiles notation (if other than submission substance): O=C(OC(=O)C1CC=C(C2)C)C12
- InChl (if other than submission substance): 1/C9H10O3/c1-5-2-3-6-7(4-5)9(11)12-8(6)10/h2,6-7H,3-4H2,1H3
- Structural formula attached as image file (if other than submission substance): see Fig. (11070-44-3 structure.png)

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no details given

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
no details given
Duration of treatment / exposure:
24 h treatment, patch test, 0.5 ml of test substance
Observation period:
24 hours and 72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch
- Type of wrap if used: rubberized cloth
SCORING SYSTEM:
erythema and eschar formation
0: no erythema, 1: very slight erythema (barely perceptible), 2: Well-defined erythema, 3: moderate to severe erythema,
4: severe erythema (beet redness) to slight eschar formation (injuries in depth)
oedema formation
0: no oedema, 1: very slight oedema (barely perceptible), 2: slight oedema (edges of area well-defined by definite raising),
3: moderate oedema (raised approximately 1 millimeter),
4: severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24/72 h
Score:
3.5
Max. score:
8
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24/72 h
Score:
2
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24/72 h
Score:
1.58
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24/72 h
Score:
1.92
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24/72 h
Score:
1.5
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
no details given
Other effects:
no details given

Any other information on results incl. tables

Rabbit no.

Reaction

24 hours

72 hours

LEFT

intact

RIGHT

abraded

LEFT

intact

RIGHT

abraded

1

Erythema

2

2

2

2

Oedema

2

2

2

2

2

Erythema

2

2

2

2

Oedema

2

2

2

2

3

Erythema

2

2

3

1

Oedema

2

2

3

1

4

Erythema

2

2

2

1

Oedema

2

2

2

1

5

Erythema

2

2

2

0

Oedema

2

2

2

0

6

Erythema

2

2

1

1

Oedema

2

2

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A mean erythema score (24/72 h) calculated over all 6 animals for intact skin of 2 and for abraded skin of 1.58 was observed. The oedema score was determined to be 1.92 for intact skin and 1.50 for abraded skin.
Taking the test conditions into account, in particular the 24 hour exposure period compared with 4 hours of current test methods (described in OECD TG 404, MTHPA has not to be classified and labelled as dermal irritant according to CLP (1272/2008/EEC), and according to 67/548/EEC (DSD).
Executive summary:

In a primary dermal irritation study, rabbits were dermally exposed to 0.5 ml of Methyl tetrahydrophthalic anhydride (MTHPA) for 24 hours. Irritation was assessed after 24 and 72 hours and reaction scored according to the Draize scale.

A mean erythema score (24/72 h) calculated over all 6 animals for intact skin of 2 and for abraded skin of 1.58 was observed. The oedema score was determined to be 1.92 for intact skin and 1.50 for abraded skin.

Taking the test conditions into account, in particular the 24 hour exposure period compared with 4 hours of current test methods (described in OECD TG 404), MTHPA has not to be classified and labelled as dermal irritant according to CLP (1272/2008/EEC), and according to 67/548/EEC (DSD).