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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According or similar to OECD Guideline 406. GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
occlusive wrap used
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: P Strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
Source: Shell Toxicology Laboratory, Breeding Unit.
Sex: Female (10) and Male (10); Controls: Males (5); Males (5)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal Injection (sensitization; first phase): 1.0% (w/v) in vehicle
Topical Induction: 50.0% w/v (occlusive dressing)
Challenge dose: 25% w/v
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Intradermal Injection (sensitization; first phase): 1.0% (w/v) in vehicle
Topical Induction: 50.0% w/v (occlusive dressing)
Challenge dose: 25% w/v
No. of animals per dose:
Control: Male (5); Female (5)
Treatment: Female (10); Male (10)
Details on study design:
Followed Magnusson and Kligman Guinea-Pig Maximization test (1969).
Challenge controls:
Vehicle controls were used for each of the induction treatments and for the challenge treatment.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: immediately after challenge
Hours after challenge:
0
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: immediately after challenge
Hours after challenge:
0
Group:
test group
Dose level:
25.0% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading:
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25.0% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25.0% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25.0% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25.0% w/v . No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Classification as a skin sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

A Magnusson and Kligman Guinea-Pig Maximization test was conducted on 20 guinea pigs with Shellsol TD. Twenty guinea pigs were treated by intradermal injection (1.0% (w/v) Shellsol TD in vehicle) to induce sensitization and then further sensitized by dermal application of 50.0% (w/v) Shellsol TD. Guinea Pigs were challenged by topical application (25.0% (w/v) Shellsol TD in corn oil). All animals survived to termination of study.  There was a very low incidence of clinical in-life observations noted throughout the test period.  Following topical challenge with 25.0% (w/v) Shellsol TD, all animals were free of dermal irritation.  Classification as a skin sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.