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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:
Nov. - Dec. 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Analog hazardous substances, Part. 191, Section 11, FDA, Washington 1965
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Weight at study initiation: males/females 2.3 - 2.8 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 60 +/-3
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
open
Preparation of test site:
other: shaved and scarified
Vehicle:
unchanged (no vehicle)
Controls:
other: 1% methyhydroxyethylcellulose Gel MH 300 P
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 2.0 ml/kg
Concentrations of test material: 1. 30% solution, 2. 15% solution
Duration of treatment / exposure:
24 hours
Observation period:
0, 24 h, 48 h, 72 h, 14 days daily
Number of animals:
36 in total, 3 per sex and group
Details on study design:
TEST SITE
- Area of exposure: 20 x 20 cm
Application of test substance: 1. intact skin 2. scarified skin

OBSERVATION
- clinical signs, water and food consumption, body weight were checked daily

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin, TMT solution 30%
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
scarified skin, TMT solution 30%
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin, TMT solution 10%
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
scarified skin, TMT solution 10%
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin, control animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
scarified skin, control animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritant response or serious lesion was noted during the 72-hour and 14 days observation period, no edema were present
Other effects:
No signs of incompatibility and no clinical effects, changes in water/food consumption or body weight gain were evident

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study under the given conditions the test item showed no corrosive or irritant effects. Based on these information, the test item does not require classification and labeling according to CLP Regulation (EC) No. 1272/2008.