Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Specific details on test material used for the study:
Identification: TMP-Ketal
Description: clear colourless liquid
Bach number: DEG 1003554

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
3 min, 1 hour, 4 hours
Observation period:
7 days
Number of animals:
One rabbit each for 3min and 1 hour treatment.
Three rattbis for 4 hour treatment

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
observation in three rabbits
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
observation in three rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

Individual Skin Reactions Following 3-Minute and 1-Hour Exposures

Skin Reaction

Observation Time

Individual Scores

3-Minutes Exposure

1-Hour Exposure

Erythema/Eschar Formation

1 Hour

0

0

24 Hours

0

0

48 Hours

0

0

72 Hours

0

0

7 Days

0

0

Oedema Formation

1 Hour

0

0

24 Hours

0

0

48 Hours

0

0

72 Hours

0

0

7 Days

0

0

Individual Skin Reactions Following 4-Hour Exposure

Skin Reaction

Observation Time

Animal 1

Animal 2

Animal 3

Erythema/Eschar Formation

1 Hour

1

0

0

24 Hours

1

0

0

48 Hours

1

0

0

72 Hours

1

0

0

7 Days

0

0

0

Oedema Formation

1 Hour

0

0

0

24 Hours

0

0

0

48 Hours

0

0

0

72 Hours

0

0

0

7 Days

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritating property of TMP-Ketal was investigated according to the Guideline OECD 404. TMP-Ketal is not irritating to skin.
Executive summary:

The skin irritating property of TMP-Ketal was investigated according to the Guideline OECD 404. TMP-Ketal is not irritating to skin.