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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Storage No.: EX0307
Chemical name: 1-[(3 -Aminopropyl)dimethyl-silyl]-2,2dimethyl- 1-aza-2-sila cyclopentane
Physical State at RT: liquid
Storage conditions: ambient, RT, protected from light
Safety precautions: Routine hygienic procedures were sufficient
to assure personnel health and safety.

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc : DH
Sex:
female
Details on test animals and environmental conditions:
10/5 (test/control) Hsd Poc : DH - guinea pigs (Full-Barrier) , Sex: female, nulliparous, body weight at the commencement ofthe study 300 - 500 g.
8 (range finding) Hsd Poc : DH - guinea pigs (Full-Barrier) , Sex: female, nulliparous, nonpregnant, body weight at the commencement of the study
300 - 500 g.
A health inspection was performed to ensure the good state of health of the animals.
The animals were derived from a controlled full barrier maintained breeding system (spf).
Source: Harlan Winkelmann GmbH, D-33178 Borchen.
Animal Husbandry
The animals were barrier maintained (semi-barrier) in air conditioned rooms
- Temperature: 22 ± 3° C
- Rel. humidity: 55 ± 10%
- Artificial light, lighting regime 12 : 12 hours, light 6.30 - 18.30
- Air change: at least 10 x / hour
- Feeding ad libitum, Altromin 3122 maintenance diet for guinea pigs, rich in crude fiber, totally-pathogen-free-TPF.
- Free access to tap water (drinking water, municipal residue control, microbiol. controlled peri-odically).
- The animals were kept in groups in Terluran - cages on Altromin saw fiber bedding. Max. group size 10 animals.
- Adequate acclimatisation period

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
cotton seed oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
5 % in Cotton Seed Oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
cotton seed oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
5 % in Cotton Seed Oil
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
For the justification of dose levels a preliminary test was performed. Five animals were topically treated with 0.5% / 1% / 2.5% / 5% / 10% / 25% / 50% and 100% concentration of the test item. There have been signs of erythema grade 4 for the 100% as well as 50% concentration 24 hours after application. There have been signs of erythema grade 1 for the 10% concentration at 24 and 48 hours readings. For the 25% concentration necrosis was found 24, 48 and 72 hours after ap-plication. No signs of irritation and systemic toxicity were recorded for the other concentrations. Therefore the 10% concentration was chosen for the topical induction and the 5% concentration for the challenge, respectively.


Induction: First Stage, Intradermal Injection
Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region which was cleared of hair by clipping so that one of each pair lies on each side of the midline.
Test group: Day 0
Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with cottonseed oil
Injection 2: Prepared Test item
Injection 3: Prepared Test item at a concentration of 50% (v/v) in Freund's Adjuvant complete, 1+1 (v/v) diluted with cottonseed oil
Control group : Day 0
Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with cottonseed oil
Injection 2: Vehicle
Injection 3: Vehicle at a concentration of 50% (v/v) in Freund's Adjuvant complete, 1+1 (v/v) diluted with cottonseed oil
Injections 1 and 2 were given close to each other and nearest to the head, while 3 is given toward the caudal part of the test area.

Induction: Second Stage, Topical Application
Test and Control Group: Day 6
Approximately twenty-four hours before the topical induction application the test area was closely clipped.
Test Group: Day 7
A patch was loaded with 0.5 ml of the prepared test item, applied to the test area and held in con-tact by an occlusive dressing for 48 hours.
Control Group: Day 7
A patch was loaded with 0.5 ml of the vehicle and applied to the test area and held in contact by an occlusive dressing for 48 hours.

Challenge: Topical Application
The flanks of treated and control animals were cleared of hair by closely clipping and the use of a depilation creme.
Test and Control Group: Day 20
A patch loaded with 0.5 ml of the prepared test item was applied to the left flank of the animals and, a patch loaded with 0.5 ml vehicle to the right flank (intraspecific control), respectively. The patches were held in contact by an occlusive dressing for 24 hours. At the end of the challenge skin was cleaned with the aid of moistened gauze patches.

Test and Control Group
Approximately 21 hours after removing the patch the challenge area was cleaned and cleared of hair. Approximately 24 hours after removing of the patch the skin reaction was observed and recorded according to the grades shown below. Two more observations were recorded 48 and 72 hours after patch removal. Additionally all animals have been observed for signs of toxicity at least once daily during the test period.


Positive control substance(s):
yes
Remarks:
Mercaptobenzothiazole

Results and discussion

Positive control results:
The positive control worked as expected.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this sensitization test it can be stated that the test item causes reactions identified as sensitization.
Executive summary:

During the induction phase of an OECD 406 skin sensitisation test with the test item in the guinea pigs (10 test group, 5 control group all females, strain: Hsd Poc: DH) were intradermally injected with 0.5% test item (diluted in Cotton Seed Oil) and topically treated with 10% test item (diluted in Cotton Seed Oil). After a latency of 2 weeks – to allow a potential reaction of the immune system - the animals were challenged with 5% test item (diluted in Cotton Seed Oil) on the flank.

The grade of skin reactions was compared to control animals, which were treated with Cotton Seed Oil during the induction stage, and during challenge phase with 5% test item, respectively.

The sensitization rate after application of test item was 90 %. Under the test conditions described below the test item showed severe sensitizing properties.

Considering the reported data of this sensitization test it can be stated that the test item causes reactions identified as sensitization.