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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles performed on an analogue substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 hour exposure, occlusive wrap
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Naphtha (petroleum), light catalytic cracked
EC Number:
265-056-2
EC Name:
Naphtha (petroleum), light catalytic cracked
Cas Number:
64741-55-5
IUPAC Name:
Naphtha (petroleum), light catalytic cracked
Constituent 2
Reference substance name:
light catalytically cracked naphtha
IUPAC Name:
light catalytically cracked naphtha

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: non-abraded and abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
24 hours
Observation period:
Observations were made at 24, 72, and 96 hours and at 7 and 14 days after treatment.
Number of animals:
6 animals
Details on study design:
Observations were not made at 48 hours. Therefore, the mean erythema and mean edema scores do not reflect a 24, 48, and 72 hour average, rather they reflect a 24 and 72 hour average.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #6
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
animal #5
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
animal #4
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 dats
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
animal #3
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
animal #2
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 14
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
14 d
Score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Irritation parameter:
edema score
Basis:
animal #1
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Out of compliance with OECD guidelines; 24 hour exposure, occlusive wrap
Other effects:
The test article was administered via an occlusive dermal patch on abraded skin. The erythema scores at 24, 72, and 96 hours and at 7 and 14 days were 1.8, 2.3, 1.5, 1.2, and 0.0, respectively. Erythema was fully reversible within 14 days after treatment. The edema scores at 24, 72, and 96 hours and at 7 and 14 days were 2.0, 1.7, 1.5, 0.2, and 0.0, respectively. Edema was fully reversible within 14 days after treatment.

Applicant's summary and conclusion

Interpretation of results:
other: Study design not appropriate to classify skin irritation.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The results of this study cannot be directly interpreted for classification of skin irritation due to deviations from the EEC regulatory protocol, consisting of the use of a 24 hr, rather than a 4 hr, exposure period and the use of an occlusive, rather than a semi-occlusive, wrap.
Executive summary:

Light catalytically cracked naphtha (API 83-20) was administered via occlusive dermal patch on non-abraded and abraded skin of 6 New Zealand White rabbits at doses of 0.5 ml for 24 hours to assess dermal irritation. Clinical observations were made at 24, 72, and 96 hours and 7 and 14 days after treatment. Light catalytically cracked naphtha produced moderate to severe levels of irritation (erythema and edema) to the skin of rabbits as a result of 24 -hour exposure. All irritation subsided by Day 14 of the study. No sign of systemic toxicity was seen during the study. The erythema and edema scores for light catalytically cracked naphtha (API 83-20) were 2.0 and 1.3, respectively. This study does not meet the EU OECD testing criteria necessary for classification.