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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Draize, J. H., Woodard, G., and Calvery, H. 0. (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Thera p. 82: 377-390.
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Terphenyl
EC Number:
247-477-3
EC Name:
Terphenyl
Cas Number:
26140-60-3
Molecular formula:
C18H14
IUPAC Name:
1,1':4',1''-terphenyl
Constituent 2
Reference substance name:
MCS-1980
IUPAC Name:
MCS-1980
Details on test material:
- Name of test material (as cited in study report): MCS 1980 (or Santowax CST)
- Molecular formula (if other than submission substance): C18H14 and C24H18
- Molecular weight (if other than submission substance): 230 and 306
- Physical state: brown solid
- Lot/batch No.: QET 1303369

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Isaac's Farm, Litchfield, Illinois
- Age at study initiation: Approximately 10 weeks (young adults)
- Weight at study initiation: 2.16-2.60 kilograms
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum (Purina Rabbit Chow® (Registered Trademark of the Ralston-Purina Company, St, Louis, Missouri))
- Water (e.g. ad libitum): ad libitum (water furnished by the City of St. Louis, Missouri)
- Acclimation period: at least five days

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A mass of 0.5 ± 0.009 grams of the test material
Duration of treatment / exposure:
single exposure, 24 h exposure
Observation period:
The initial (day one) observation for skin irritation was made approximately one hour after the removal of the wrappings. Results were recorded at 24 and 72 hours after topical application. The animal that had irritation present during the 72 hour examination was also observed for signs of irritation on the seventh and tenth days after exposure.
Number of animals:
3 animals per sex
Details on study design:
TEST SITE
- Area of exposure: dorsal surface
- % coverage: The test material was applied to the skin under one inch square gauze patches
- Type of wrap if used: wrap of latex rubber secured by bandaging and elastic tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess material was wiped from the treated sites of the animals
- Time after start of exposure: aproximately 24 hours

SCORING SYSTEM: Dermal irritation was scored by the method of Draize (1944)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.1
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Intact and abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.13
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact and abraded skin
Irritant / corrosive response data:
All skin irritation had subsided by the tenth day after test material administration. Defatting of the skin on all four exposed sites occurred in one animal on the tenth day after exposure. No signs of systemic toxicity were observed.

Any other information on results incl. tables

Primary skin irritation score summary:

Period (days)

Erythema

Edema

Irritation score

Intact

Abraded

Mean

Intact

Abraded

Mean

1

0.0

0.1

0.0

0.0

0.0

0.0

0.0

3

0.2

0.2

0.2

0.0

0.0

0.0

0.2

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The key study for skin irritation/corrosion is a K1 GLP study performed similar to OECD guideline 404, in which the Draize scoring system is used. New Zealand White rabbits were exposed to 0.5g of the test material for 24 hours under occlusive coverage upon both intact and abraded shaved skin. Subsequently, the excess material was wiped from the treated sites of the animals. Scorings were recorded 24 and 72 hours after topical application. Animals showing signs of irritation after 72 hours were further observed for signs of irritation on the seventh and tenth day after exposure. Only signs of slight erythema were observed.