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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:
No information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Grey literature deficient in some details of methodology but considered adequate for the purposes of hazard identification and classification.

Data source

Reference
Reference Type:
grey literature
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Observations made at 24 and 72 hours only; use of abraded skin sites
Principles of method if other than guideline:
Pre-dates but is broadly comparable to OECD 404
GLP compliance:
no
Remarks:
pre-dates the introduction of GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No further information

Test system

Type of coverage:
not specified
Preparation of test site:
other: abraded and unabraded
Vehicle:
other: The test material was applied undiluted and also as a 5% concentration in diethylphthalate
Controls:
other: Untreated intact and abraded skin sites served as controls on the same rabbits
Amount / concentration applied:
No data
Duration of treatment / exposure:
No data
Observation period:
The treated and untreated areas were observed after 24 and 72 hours for signed of irritation and were scored by the method of Draize
Number of animals:
No information available
Details on study design:
Linalyl Isobutyrate was applied to abraded and unabraded sites on rabbit skin undiluted and as a 5% concentration in diethylphthalate. Three rabbits were used for each concentration tested . Untreated intact and abraded skin served as controls on the same rabbits. The treated and untreated areas were observed after 24 and 72 hours for signed of irritation and were scored by the method of Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(undiluted / non abraded)
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
no data
Remarks on result:
other: Grade 1-2 erythema observed in all animals
Irritation parameter:
erythema score
Remarks:
(undiluted / non abraded)
Basis:
mean
Time point:
other: 72 h
Score:
1.67
Max. score:
4
Reversibility:
no data
Remarks on result:
other: Grade 1-2 erythema observed in all animals
Irritation parameter:
edema score
Remarks:
(undiluted / non abraded)
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant
Remarks on result:
other: No oedema observed in any animal
Irritation parameter:
edema score
Remarks:
(undiluted / non abraded)
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant
Remarks on result:
other: No oedema observed in any animal

Any other information on results incl. tables

Undiluted linalyl isobutyrate

Time point

24 Hours

72 Hours

Application site

Abraded

Non-abraded

Abraded

Non-abraded

Rabbit

A

B

C

A

B

C

A

B

C

A

B

C

Erythema

1

1

1

1

1

2

2

1

2

2

1

2

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

 

Diluted linalyl isobutyrate (5% in diethyl phthalate)

Time point

24 Hours

72 Hours

Application site

Abraded

Non-abraded

Abraded

Non-abraded

Rabbit

A

B

C

A

B

C

A

B

C

A

B

C

Erythema

1

0

1

1

0

1

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Undiluted linalyl isobutyrate caused mild skin irritation (Grade 1or 2 erythema) when applied to abraded and non-abraded sites on rabbit skin. No oedema was observed. Although full reversibility of effects was not demonstrated within the 72 hour period, effects are not considered to be of sufficient severity to warrant classification according to the CLP Regulation.