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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:
7-10 Oct 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2015
Deviations:
yes
Remarks:
Occlusive dressing instead of semi-occlusive dressing was used.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed

Test animals

Species:
rabbit
Strain:
other: Hra:(NZW)SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products lnc. (Denver, PA)
- Age at study initiation: at least three months old
- Weight at study initiation: at least 2000 g
- Housing: individually housed in suspended, stainless-steel mesh cages in an American Association for Accreditation of Laboratory Animal Care-accredited vivarium
- Diet: certified High Fiber Rabbit Diet (PMI® #5325) available ad libitum
- Water: local public water system available ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 60-68
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g moistened with water
Duration of treatment / exposure:
4 h
Observation period:
The site of application was examined at 1, 24, 48, and 72 hours after removal of the occlusive patch.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal skin
- % coverage: not reported
- Type of wrap if used: occlusive

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

OBSERVATION TIME POINTS
The site of application was examined at 1, 24, 48, and 72 hours after removal of the occlusive patch.

SCORING SYSTEM:
- Method of calculation: Graded as described in OECD Guideline 404 (Annex V., Test B.4) (Grading of Skin Reaction)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
Conclusions:
In the reliable skin irritation study performed with N-(2-(( 4-Amino-3-methylphenyl)ethylamino) ethyl)methanesulfonamide sulfate (2:3) monohydrate (CAS 25646-71-3) according to OECD TG 404 three albino rabbits were exposed to 0.5 g of the neat test material for 4 h applied onto the shaved skin via occlusive dressing. No edema formation was observed in any animal. The mean values for erythema and edema were calculated to be 0, respectively. Therefore, the test substance does not need to be classified for skin irritation according to Regulation (EC) No 1272/2008.