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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19-Jun-1997 to 04-Sep-1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
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): Kalcol 2098 (lauryl alcohol)
- Substance type: no data
- Physical state: no data
- Analytical purity: <=98%
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 3531
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC Co.
- Age at study initiation: 5 weeks
- Weight at study initiation: 304 to 355 g
- Housing: 5/cage; aluminium cages with stainless steel wire mesh floors (350 x 400 x 200 mm)
- Diet (e.g. ad libitum): standard pelleted guinea pig diet (RC-4), ad libitum
- Water (e.g. ad libitum): tap water 5 um-filtered, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +- 2
- Humidity (%): 50 +- 10
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 24-Jun-1997 To: 04-Sep-1997

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: liquid paraffin
Concentration / amount:
3 and 6% intracutaneous induction, 50% epicutaneous induction; 3 and 10% epicutaneous challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: liquid paraffin
Concentration / amount:
3 and 6% intracutaneous induction, 50% epicutaneous induction; 3 and 10% epicutaneous challenge
No. of animals per dose:
10 test, 5 control
Details on study design:
RANGE FINDING TESTS:
- 8 females
- concentrations for intracutaneous application: 10, 5, 3, 1, 0.3, 0.1, 0% in liquid paraffin
- concentrations for occluded epicutaneous application (presumably 7 days later): undiluted, 30 and 10% in liquid paraffin
- evaluated for skin irritation at 24, 48 and 72 hours after intracutaneous application
- evaluated for skin irritation at 3, 24 and 48 hours after epicutaneous application

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2, intracutaneous and occluded epicutaneous
- Exposure period: epicutaneous induction 7 days after intracutaneous induction; epicutaneous challenge 21 days after intracutaneous induction
- Test groups: 10 females
- Control group: 5 females
- Site: intracutaneous induction in the shaved skin area (~ 4 x 6 cm), symmetrically on both sides of the midline in the scapular region, test animals received (a), (b) and (c), controls received (a), (d) and (a); epicutaneous induction at initially exposed skin site shaved again, test animals received (e), control animals received (d)
- Frequency of applications: epicutaneous induction 7 days after intracutaneous induction
- Duration: epicutaneous induction 48 hours
- Concentrations: (a) 1:1 water-in-oil emulstion of Freunds complete adjuvant (FCA) and physiological saline, (b) test material at 3% in liquid paraffin, (c) 1:1 emulsion of test material at 6% in FCA and physiological saline, (d) liquid paraffin, (e) 0.2 ml of test substance at 50% in liquid paraffin

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 days after intracutaneous induction
- Exposure period: 24 hours occlusive
- Test groups: 10 females
- Control group: 5 females
- Site: flank, clipped and shaved
- Concentrations: (f) 0.1 ml test substance at 10, 3 and 0% in liquid paraffin
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches

OTHER:
- General condition
- Body weight
- Rechallenge: not required
Challenge controls:
Yes
Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene and formalin, not concurrent, results from 12 tests at same testing facility

Results and discussion

Positive control results:
Evidence presented over a relevant time period that the strain of guinea pig did respond to known sensitisers

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
challenge: 0, 3 and 10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: challenge: 0, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
challenge: 0, 3 and 10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: challenge: 0, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
challenge: 0, 3 and 10%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: challenge: 0, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
challenge: 0, 3 and 10%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: challenge: 0, 3 and 10%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.

Any other information on results incl. tables

RESULTS OF RANGE FINDING TEST:

Following intradermal injection significant skin irritation was seen at concentrations of 5 and 10% persisting for 72 hours. The 3% concentration showed evidence of irritation at 24 hours only. Following topical application the undiluted material was irritant up to 48 hours, 2/4 guineapigs showed irritation at 10% while there was  no evidence of irritation with the 3% concentration.

RESULTS OF TEST
- Rechallenge: Not required.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In a reliable study, conducted to OECD guideline 406, Kalcol 2098 was not a skin sensitiser in guinea pigs. The study was performed in compliance with GLP.