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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:
April 07th, 1992 to May 08th, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was not valid at time of test conduct

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Remazol-Brillantblau R spez.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: mean 315 g; range: 262 g to 345 g; n = 15
- Housing: group-housing (5/cage)
- Diet: Altromin 3112 for guinea pigs and rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: ca. 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: April 07th, 1992 to May 08th, 1992

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Intradermal: 5%
dermal induction: 100%
dermal challenge: 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Intradermal: 5%
dermal induction: 100%
dermal challenge: 100%
No. of animals per dose:
Determination of primary not irritating concentration: 6
Determination of intradermal tolerability: 3
Sentinel group: 5
Control group: 5
Treatment group: 10
Details on study design:
RANGE FINDING TESTS:

Determination of the primary non-irritant concentration:
In a dermal-occlusive test for primary skin irritation, each of the following test concentrations was applied to the left flank of two guinea pigs:
25.0 % Remazol-Brillantb1au R spez. in isotonic saline
5.0 % Remazol-Brillantb1au R spez. in isotonic saline
1.0 % Remazol-Brillantb1au R spez. in isotonic saline
The hair on the left flanks of the animals was removed mechanically. 0.5 mL of the test substance preparation was applied to a 2 x 2 cm cellulose patch, which was then fixed to the left flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and oedema

Determination of the tolerance of intradermal injections:
To determine the tolerance of intradermal injections, each of the following preparations (5.0%, 1.0%, 0.2% in isotonic saline) was administered twice by intradermal injection to 3 guinea pigs. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulder.


MAIN STUDY
A. INTRADERMAL INDUCTION
- No of Injections: 2 x 3 preparations: 50% FCA, 5% TS in 0.9% NaCl, 5% TS in 50% FCA - treatment group
50% FCA, 0.9% NaCl, 50% FCA - control and attending group
- Exposure period: Injection on Day 1, observation Day 1 to Day 7
- Site: shoulder

B. DERMAL INDUCTION EXPOSURE
- No. of exposures: one
- Exposure period: 48 hours
- Test groups: 25% TS in 0.9% NaCl
- Control group: 0.9% NaCl
- Site: shoulder
- Frequency of applications: single
- Duration: Day 8 to Day 22
- Concentrations: 25%

C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22 (15 for attending group)
- Exposure period: 24 hours
- Test groups: 25% TS + 0.9% NaCl
- Control group: 25% TS + 0.9% NaCl
- Site: right flank: TS; left flank: 0.9% NaCl
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
In addition to the control group, 5 further guinea pigs (attending group) were used to confirm that challenge exposure with 25% TS would not lead to dermal irritation in animals pre-treated with 50% FCA.
Positive control substance(s):
yes
Remarks:
bi-annually tested

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
blue staining of skin
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: blue staining of skin.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
blue staining of skin
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: blue staining of skin.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not sensitizing in pirbright white guinea pigs.

Classification: not sensitizing
Executive summary:

Testing for sensitizing properties of Remazol-Brilliantblau R spez. was performedin female Guinea pigs according to the method of MAGNUSSON &KLIGMAN. Intradermal induction was performed using 5% Remazol-Brillantblau R spez.in isotonic saline. Dermal induction and challenge treatment were carried out with 25% Remazol-Brilliantblau R spez. in isotonic saline.

Based on the results of this study Remazol-Brilliantblau R spez. showed no evidence for sensitizing properties.