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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: Guideline study, to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
Molecular formula:
C11H22O
IUPAC Name:
Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
Test material form:
other: liquid
Details on test material:
Identification: Super Muguet
Description: Clourless to pale yellow liquid
Batch Number: 9000408259
Purity: 99.9%
Stability of test item: Stable under storage conditions
Expiry date: 08-12-2002
Storage Conditions: In the original container, at room temperature (range 17-23 °C), away from direct sunlight.
Safety Precautions: Routine hygenic procudures were used to ensure the health and safety of the personnel.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Test system: New Zealand White Rabbit, SPF
Rationale: Recognized by the international guidelines as the recommended test system
Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
Number of animals per test: 3 (Animals of both sexes were used)
Ages at start of treatment: 12-13 weeks (male), 10-11 weeks (female)
Body weights at start of treatment: 2.1-2.3 kg
Identification: By unique cage number and corresponding ear number
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL per animal
Duration of treatment / exposure:
The duration of treatment was 4 hours.
Observation period:
The scoring of the skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing.
Number of animals:
3 animals per test

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
mean
Basis:
animal #1
Time point:
other: mean: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Remarks:
mean
Basis:
animal #2
Time point:
other: Mean: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Remarks:
mean
Basis:
animal #3
Time point:
other: Mean: 24, 48 and 72 hours
Score:
1.67
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
mean
Basis:
animal #1
Time point:
other: Mean: 24, 48 and 72 hours
Score:
1.33
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
mean
Basis:
animal #2
Time point:
other: Mean: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Remarks:
mean
Basis:
animal #3
Time point:
other: Mean: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
no data
Irritant / corrosive response data:
The mean score was calculated across 3 scoring times ( 24, 48 and 72 hours after patch removal) for each animal for eryherma/eschar grades and for oedema grades, separately. The mean eryherma/eschar score of the three animals was 2.00, 2.00 amd 1.67, respectively and the mean oedema score was 1.33, 1.00 and 1.00, respectively.

Well-defined erythema was observed in all animals 1 hour after treatment and persisted in two animals up to the 72-hour reading and in the other animal up to 48-hour reading. In addition, very slight erythema was evident in one animal at the 72-hour reading and in the other two animals at both the 7- and 10- day readings.

Very slight to slight swelling was noted at the test site of all animals from 1 to 72 hours after treatment.

Scaling was first observed at the test site of one animal 72 hours after treatment and in the other two animals 7 das after treatment. This finding was still present on all animals on test day 14 at termination.
Other effects:
No staining by the test item of the treated skin was observed.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Applicant's summary and conclusion

Interpretation of results:
other: Irritation observed, but not sufficient for classification.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
.
Executive summary:

In an in vivo study, conducted to GLP, according to the OECD Guideline 404, undiluted Super Muguet (0.5 mL) was applied to the skin of 3 New Zealand White Rabbits for 4 hours.

The mean score was calculated across 3 scoring times ( 24, 48 and 72 hours after patch removal) for each animal for eryherma/eschar grades and for oedema grades, separately. The mean eryherma/eschar score of the three animals was 2.00, 2.00 amd 1.67, respectively and the mean oedema score was 1.33, 1.00 and 1.00, respectively.