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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Berolamine AA15. pre-guideline, pre-GLP. No data on positive control or reliability check is given.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Remarks:
Pre-GLP; signed authentication form present
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
EC Number:
629-757-0
Cas Number:
1224966-15-7
Molecular formula:
UVCB, no structural formula can be set
IUPAC Name:
Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products
Details on test material:
Name: BEROLAMINE AA15, a amide/imidazoline of Berolamine 20 and a fatty acid.
Described: dark brown highly viscous liquid.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Porcellus Animals Ltd
- Age at study initiation: Not indicated
- Weight at study initiation: 300-400 g
- Housing: 5 per cage
- Diet (e.g. ad libitum): BP Nutrition FDI diet, at lib.
- Water (e.g. ad libitum): Source not specied; ad lib.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS: Not indicated
IN-LIFE DATES: From: 4 april 1979 To: 27 April 1979

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal: 1% (w/w) testsubstance in water
Topical induction: 5% (w/w) in water (slightly irritant)
Topical challenge: 2% (w/w) in water (non-irritant)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Intradermal: 1% (w/w) testsubstance in water
Topical induction: 5% (w/w) in water (slightly irritant)
Topical challenge: 2% (w/w) in water (non-irritant)
No. of animals per dose:
10 animals with test substance in treatment group, 7 animals in control group.
Details on study design:
RANGE FINDING TESTS:
Determination of maximum non-irritant concentration in two guinea pigs that were pretreated as the induction phase. Material was tested under occlusive patch system used for topical induction in concentrations of 10%, 5%, 2% and 1.0% (w/w) in water.
Test substance was slightly irritating at 5%. A concentration of 2% in water was selected for th challenge of the test group.

MAIN STUDY
A. INDUCTION EXPOSURE
- Test group: 10 animals
1. intradermal: Two rows of three intra dermal injections on each side of the midline across the shaved scapular region.
0.1 ml Freund's Complete Adjuvant (FCA) alone
0.1 ml test agent (1% w/w) alone
0.05 ml test agent (1% w/w) emulsified with 0.05 ml FCA.
2. One topical application 6 days later:
Injection side shaved and treated with 10% lauryl sulphate for mild inflammatory response. Solution was massaged into the backs, kept unbandaged for 24 hours. Then a 2x2 cm patch (Whatman no. 3 MM filter) saturated with 5% w/w test substance, and covered by impermeable plastic adhesive tape (Blenderm). The whole area was then firmly bound by Sleek acclusive tape and dressing was left in place for 48 hours.

- Control group: 5 animals
1. intradermal: Two intra dermal injections of FCA only on each side of the midline across the shaved scapular region.
2. No topical induction

B. CHALLENGE EXPOSURE
Test group and control group:
Two weeks after topical induction, a 2% test substance solution was applied to the shave right flank of the animals using the same method as for topical induction. The patch was removed after 24 hours. The response was determined 24 hours after removal of the challenge patch.

C. RESPONSE
Any animal showing erythema at the site of challenge would be considered to have shown a positive response.
Challenge controls:
Control group consisted of 7 animals similar to treatment group.
Controls only received FCA injections. Two animals were used for determining teh maximum test substance concentrations to be used for induction and challenge.
Positive control substance(s):
no

Results and discussion

Positive control results:
No positive control or information on reliability is given.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2% w/w in water
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2% w/w in water. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
2% w/w in water
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2% w/w in water. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Substance was not senstisiting in the Guinea pig maximisation test
Executive summary:
Berolamine AA15 was tested according the Magnusson-Kligman Guinea pig maximisation test (similar to OECD 406). Berolamine AA15 did not elicit positive responses in the test group after challenge of the 10 guinea pigs by topical application with 2% aq. solution. From these results it is concluded that this product is a non-sensitiser in guinea pigs.

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