Registration Dossier

Administrative data

Description of key information

The substance is considered as not sensitizing to the skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
The test article name was completed. In addition to the highest non-irritating test substance concentration a lowest test substance concentration was applied in the second challenge.
Principles of method if other than guideline:
Guideline followed
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Specific details on test material used for the study:
None
Species:
guinea pig
Strain:
Himalayan
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratory Limited
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 298 -395 g
- Housing: Individually in Makrolon type - 3 cages (Size: 22 x 37 x 15 cm) with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + or - 3 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10 to 15 air changes / hour
- Photoperiod (hrs dark / hrs light): 12 hrs artificial fluorescent light and 12 hrs dark

IN-LIFE DATES: From: 26 Jan 1993 To: 27 April 1993
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5%
Day(s)/duration:
Day 0
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
other: vaselinum album
Concentration / amount:
25%
Day(s)/duration:
Day 7
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaselinum album
Concentration / amount:
25%
Day(s)/duration:
Two weeks after the epidermal induction application
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: vaselinum album
Concentration / amount:
25 and 15%
Day(s)/duration:
Two weeks after the first challenge
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Control group: 10 female albino guinea pigs
Test group: 20 female albino guinea pigs
Details on study design:
RANGE FINDING TESTS:
Intradermal Injections:
Intradermal injections (0.1ml/site) were made into the clipped flank of two guinea-pigs at concentrations of 5, 3 and 1 % of the test article in physiological saline. The resulting dermal reactions were assessed 24 hours later.

Epidermal application:
Patches of filter paper (2 X 2 cm) were saturated with concentrations of 5, 10, 15 and 25 % of the test article in vaselinum album and applied to the clipped and shaved flanks of each of the four guinea-pigs. The patches were covered by a strip of aluminium foil and firmly secured by elastic plaster wound round the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test article. The dressing were removed after an exposure period of 24 hours and the reaction sites were assessed for erythema and edema on a numerical basis according to the scale described above. Further examination of the sites were performed 24 and 48 hours after removal of the dressing.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 24 hr
- Test groups: 1) Freund's complete adjuvant 50:50 with physiological saline.
2) The test article, diluted to 5 % in physiological saline.
3) The test article diluted to 5 % by emulsion in a 50:50 mixture of Freund's complete adjuvant and physiological saline.
- Control group: 1) Freund's complete adjuvant 50:50 with physiological saline.
2) physiological saline.
3) Freund's complete adjuvant 50:50 with physiological saline.
- Site: right and left flanks of the Guinea pig.
- Frequency of applications: 1
- Duration: 24 hr
- Concentrations: 5 %

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 2 weeks
- Exposure period: 24 hr
- Test groups: 25 % test article in vaselinum album
- Control group: Vaselinum album
- Site: Left and right flank
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 hr

Challenge controls:
Epidermal application: The guinea-pigs of the control group were treated as described above with the omission of test article (vaselinum album only).

Intradermal injection:
1) Freund's complete adjuvant 50:50 with physiological saline.
2) physiological saline.
3) Freund's complete adjuvant 50:50 with physiological saline.
Positive control substance(s):
yes
Positive control results:
The intradermal induction was performed with a dilution at 5% in acetone. For the induction period and challenge procedure a 25& dilution of 2-MERCAPTOBENZOTHIAZOL in acetone was used. This concentration was found in a pretest to be the highest primary not-irritant concentration.
According to the results observed it is considered that the known allergen 2-MERCAPTOBENZOTHIAZOL possess a moderate skin sensitizing potential in the guinea pig strain used (Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted); BRL, Biological Research Laboratories Ltd., CH-4414 Füllinsdorf)
Key result
Reading:
other: 1st reading after first challenge
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
2
Total no. in group:
19
Clinical observations:
No adverse effects
Remarks on result:
other: One test animal was found dead at test day 14, six days after the epidermal induction application.
Key result
Reading:
other: 2nd reading after first challenge
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
2
Total no. in group:
19
Clinical observations:
No adverse effects
Remarks on result:
other: One test animal was found dead at test day 14, six days after the epidermal induction application.
Key result
Reading:
other: 1st reading after second challenge
Hours after challenge:
24
Group:
test group
Dose level:
25% on POSTERIOR RIGHT FLANK and 15% on ANTERIOR RIGHT FLANK
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
No clinical signs
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 2nd reading after second challenge
Hours after challenge:
48
Group:
test group
Dose level:
25% on POSTERIOR RIGHT FLANK and 15% on ANTERIOR RIGHT FLANK
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
No clinical signs
Remarks on result:
no indication of skin sensitisation

None

Interpretation of results:
GHS criteria not met
Conclusions:
This test article is considered not to be a sensitizer.
Executive summary:

This study was performed to assess the allergenic potential of LANASOL ROT 2G ROH TROCKEN (FAT 92'348/A) in albino guinea pigs by following OECD Test guideline 406 and in accordance to GLP principles.

Ten females were used as control group and 20 females were used as test group.

In this study 11 % of the animals were positive after the first challenge when treated with a non-irritant test substance concentration of 25%. After the second challenge no skin reactions were observed in the animals treated with a 25 % and 15 % test substance concentration.

Hence, according to EEC (European Economic Community) classification criteria described in guidelines 91/325/EEC (EC Official Journal Nr. L 180, July 08, 1991), this test article is considered not to be a sensitizer.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

This study was performed to assess the allergenic potential of LANASOL ROT 2G ROH TROCKEN (FAT 92'348/A) in albino guinea pigs by following OECD Test guideline 406 and in accordance to GLP principles. Ten females were used as control group and 20 females were used as test group. No allergenic potential of the test article LANASOL ROT 2G ROH TROCKEN (FAT 92'348/A) was observed. The results were judged according to the rating of Magnusson and Kligman (1969).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance LANASOL ROT 2G ROH TROCKEN (FAT 92'348/A) was observed to be non-sensitising in albino Guinea pigs. Therefore, no EU CLP classification is warranted.