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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: according to information in OECD SIDS (2002)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976
Reference Type:
publication
Title:
Unnamed
Year:
2002

Materials and methods

Principles of method if other than guideline:
Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. 2 animals were treated for 1, 5 and 15 minutes and for 20 hours usually using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the moistened test substance using cotton patches of this size.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): THEIC
- Physical state: solid
- Analytical purity: ca. 99%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler (breeder)
- Weight at study initiation: 3.14kg and 3.3 kg


ENVIRONMENTAL CONDITIONS
not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 1 mL (80% aqueous solution) administered using cotton patches of 2.5 x 2.5 cm size.
Duration of treatment / exposure:
Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 h
Observation period:
8 days (observations at 1, 3, 4, 7 and 8 days post patch removal)
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure:
An application site of 2.5 X 2.5 cm was covered with the aqueous solution of the test substance (37°C; approx. 1 ml) using a cotton pad of this size.

REMOVAL OF TEST SUBSTANCE

Experiment 1:
Washing of the treated skin in the 1 min, 5 min and 15 min test immediately after the respective treatment period. Concentrated Lutrol (a mild detergent) and a 50% aqueous solution therof was used for washing.

Experiment 2: No washing was done after the 20 h treatment period.

SCORING SYSTEM:
Descriptive grading in the raw data: no effect / questionable / slight / strong / very strong.
In addition, indication of the type of finding as appropriate: erythema / edema / scale formation / necrosis / scar.
The descriptive scores in the raw data were converted into OECD/ Draize scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
after 20 h treatment period
Basis:
animal #1
Time point:
24 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Treated skin was not washed after the 20 h treatment period. Skin irritation was evaluated after 24 h and 72 h but not after 48 h.
Irritation parameter:
erythema score
Remarks:
after 20 h treatment period
Basis:
animal #2
Time point:
24 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Treated skin was not washed after the 20 h treatment period. Skin irritation was evaluated after 24 h and 72 h but not after 48 h.
Irritation parameter:
edema score
Remarks:
after 20 h treatment period
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Treated skin was not washed after the 20 h treatment period
Irritation parameter:
edema score
Remarks:
after 20 h treatment period
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Treated skin was washed after the 20 h treatment period
Other effects:
No other effects were evident.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating according to EU regulation
Conclusions:
Based on the results of the present study, the test substance has not to be classified as skin irritant following EU CLP requirements. At 48 h post patch removal, skin irritation was not recorded. Nevertheless, in view of only minimal findings at 24 h and the absence of findings at 72 h post patch removal, the study result is fully conclusive regarding classification and labelling according to EU regulations.