Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 (Tunstall), Breeding Unit.
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
intradermal induction: 0.1%
epicutaneous induction: 5%
epicutaneous challenge: 2.5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
intradermal induction: 0.1%
epicutaneous induction: 5%
epicutaneous challenge: 2.5%
No. of animals per dose:
20 in test group; 10 in control group
Details on study design:
Sensitization potential in guinea pigs was evaluated using the Magnusson and Kligman method, which involves injection of 2x0.1 ml Freund's complete adjuvant, intradermal induction with 2x0.1 ml test material in corn oil (0.1%) and 2x0.1 ml test material in 50:50 Freund's complete adjuvant/solvent (0.1%), then epicutaneous induction with 5% in corn oil and epicutaneous challenge with 2.5% in corn oil.

RANGE FINDING TESTS: A preliminary screen used groups of 2 male and 2 female guinea pigs to determine concentrations of test material to be used for intradermal and topical inductions, and topical challenge. No details were given.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: topical induction one week after intradermal induction
- Test groups: 1
- Control group: 1 (treated as test group with the omission of the test material)
- Site: shoulder region
- Duration: not relevant for intradermal; 48 hours (topical)
- Concentrations: 0.1% (intradermal); 5% (topical, occlusive)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after topical induction
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: Flank
- Concentrations: 2.5% (occlusive)
- Evaluation (hr after challenge): 0, 24 and 48

No rechallenge.

EXAMINATIONS
- Grading system: 4 point scale -ve, trace, +ve, ++ve.

Challenge controls:
yes
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
No statistics used

Results and discussion

Positive control results:
none

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In a reliable study performed using a protocol similar to OECD guideline 406, Dobanol 25 was not sensitising to the skin of guinea pigs after a topical challenge with 2.5% when tested using the method of Magnusson and Kligman.

Classification: not sensitizing