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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP status not known, near guideline study, published in peer reviewed literature, minor restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
publication
Title:
The toxicological properties of hydrocarbon solvents
Author:
Hine CH, Zuidema HH
Year:
1970
Bibliographic source:
Industrial Medicine 39, 215-200.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test substance was applied to intact and abraded skin of 6 shaved rabbits. The application sites were covered in gauze for 24 hours. Skin irritation was assessed using the Draize numerical scoring system at 24 and 72 hours.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
mixed xylenes
IUPAC Name:
mixed xylenes
Constituent 2
Chemical structure
Reference substance name:
Xylene
EC Number:
215-535-7
EC Name:
Xylene
Cas Number:
1330-20-7
Molecular formula:
C8H10
IUPAC Name:
xylene
Details on test material:
C-8 aromatics (ortho, meta and para xylene; ethyl benzene; composition not defined). Boiling Range 138-141C.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Male rabbits 2-3 kg body weight.

Test system

Type of coverage:
other: gauze
Preparation of test site:
other: shaved, intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
not stated
Duration of treatment / exposure:
not stated
Observation period:
24 and 72 hours
Number of animals:
6
Details on study design:
A maximum of 4 samples was applied to each rabbit.
Comment: guideline methodology would require 4 hour semi-occluded contact.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
2.21
Reversibility:
no data
Remarks on result:
other: mean score for erythema and oedema for both intact and abraded skin
Irritation parameter:
erythema score
Remarks on result:
other: mean score for erythema and oedemafor both intact and abraded skin
Irritant / corrosive response data:
All six rabbits were affected on both intact and abraded skin. Individual scores ranged from 1 to 4.

Applicant's summary and conclusion

Interpretation of results:
other: moderately irritating
Remarks:
Criteria used for interpretation of results: other: primary irritation index descriptive rating
Conclusions:
Mixed xylene (C-8 aromatics) was a possible borderline skin irritant in this study.
Executive summary:

Mixed xylenes (C-8 aromatics) were applied to the intact and abraded skin of six shaved rabbits. Application areas were covered with gauze for 24 hours and readings for skin irritation, according to the method of Draize, were made at 24 and 72 hours. Mixed xylenes were found to be moderately irritating under these conditions, with a Primary Dermal Irritation Index of 2.21.

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