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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: Study in full compliance with OECD guideline.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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): Tercarol 5903, NLP # 10 (ortho-Toluene diamine, propoxylated)
- Lot/batch No.: VD 04080734
- Molecular weight: Mn = 340 g/mole
- Physical state: viscous fluid
- Storage condition of test material: room temperature
- Expiration date of the lot/batch: 2009-04-30

Test animals

Species:
rabbit
Strain:
other: Crl: KBL(NZW)BR
Details on test animals and environmental conditions:
according to guideline
sex of the test animals: female

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The surrounding untreated skin served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal. If dermal irritation was observed, additional monitoring on day 7 and 14 after patch removal was done.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully washed with water

EXPOSURE PROCEDURE:
Due to a possible irritant potential of the test substance, in the first step only one animal was used and three patches were applied simultaneous. The first patch then was removed after three minutes. If no serious skin reactions were observed, the second patch was removed after one hour. If again no serious skin reactions were observed, the exposure was allowed to extend to four hours. Testing was then completed using two additional animals exposed for four hours.


SCORING SYSTEM: Draize; any serious lesions or toxic effects other than dermal irritation were also recorded and fully described.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: mean score after 72 h: 0.3
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
There were no systemic intolerance reactions.

Any other information on results incl. tables

Animal #2 showed 1 hour post application an erythema grade 1, which was fully reversible within 1 day.

Applicant's summary and conclusion

Executive summary:

An acute dermal irritation/corrosion test (OECD 404) was performed with NLP # 10 (ortho-Toluene diamine, propoxylated). According to classification criteria NLP # 10 is not an irritant to the skin. There were no systemic intolerance reactions.