Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited study details are provided, preGLP

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Versatic 10
- Substance type: liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Internal strain, no additional details provided
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shell Toxicology Laboratory

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 ml test material in 50:50 Freund's complete adjuvant and corn oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1 ml test material in 50:50 Freund's complete adjuvant and corn oil
No. of animals per dose:
5 per sex per dose
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE - INTRADERMAL INJECTION
- No. of exposures: 2
- Exposure period: 1 week
- Test groups: single group
- Control group: Freund's complete adjuvant or corn oil
- Site: each side of the midline in the shorn skin of the shoulder region

B. INDUCTION EXPOSURE - TOPICAL APPLICATION
- No. of exposures: 2
- Exposure period: 1 week after intradermal injection
- Test groups: single group
- Control group: Freund's complete adjuvant or corn oil
- Site: each side of the midline in the shorn skin of the shoulder region
- Concentrations: 0.1 ml via occluded patch.

C. CHALLENGE EXPOSURE
- No. of exposures: Single 24 hour exposure
- Day(s) of challenge: 2 weeks after topical application
- Test groups: yes
- Control group: yes
- Site: 3x3 cm area on flank
- Evaluation (hr after challenge): 24 and 48 hours after removal

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Not sensitizing
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Not sensitizing.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Neodecanoic acid is not sensitizing.
Executive summary:

In this study, neodecanoic acid was examined for skin sensitization potential in the guinea pig maximization procedure of Magnusson and Kligman.

 

A preliminary screen was carried out to determine the concentrations of test material to be used for intradermal induction, topical induction, and topical challenge. Two male and female guinea pigs were used for each test concentration.

 

Groups of ten male and ten female guinea pigs were used for the test and a further five males and five females as controls. 

 

Induction was accomplished in two stages. 

 

1) Intradermal injection

Two rows of three injections were made, one on each side of the midline in the shorn skin of the shoulder region. 

 

2) Topical application

One week after the intradermal injections, the same area was clipped free from hair. A 4x4 cm patch of filter paper was soaked in a solution of the test material and placed over the injection sites and covered with an occlusive dressing. The dressing was left in place for 48 hours. 

 

The challenge procedure was carried out two weeks after topical induction. Challenge was accomplished by topical application of the test material to the flank of animals via an occluded patch. The challenge lasted 24 hours. 

 

Immediately after the challenge, and then again at 24 and 48 hours later, each animals was examined for signs of skin sensitization.

 

At no point was there any evidence of skin sensitization produced by neodecanoic acid.