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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
yes
Remarks:
only 10 instead of 20 animals were used
Qualifier:
according to
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A valid Buehler test conducted comparable to guideline with acceptable restrictions is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Males (357-406 g); Females (381-452 g)
- Housing: 1-4 per cage (males separate from females) in suspended stainless steel cages with wire bottom
- Diet (e.g. ad libitum): Guinea Pig Diet #5025, PMI Feeds Inc., ad libitum
- Water (e.g. ad libitum): municipal tap water, ad libitum- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 72°F±5
- Humidity (%): 30-80
- Air changes (per hr): 10-12
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
once weekly (on days 1, 8, 15); 6 h/d
Adequacy of induction:
other: non-irritant substance; pre-treatment not required for Buehler test
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
on day 29; 6 h exposure
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
pretest: 4 (2 m / 2 f)main study: 10 (5 m/ 5 f)
Details on study design:
RANGE FINDING TESTS:
2 f and 2 m guinea pigs were selected for irritation screening to determine both the maximum dose producing no more than moderate irritation and the maximum nonirritating dose.
Tested concentrations: 100% (400 mg of test substance moistened with 300 µL deionized water), 75%, 50% and 25 % w/v concentrations of the test substance in deionised water.

MAIN STUDYA. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance
- Control group: no treatment
- Site: lateral (left) from midline on the back
- Frequency of applications: once weekly (on days 1, 8, 15)
- Concentrations: 100%, moistened with deionised water

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 29
- Exposure period: 6 h
- Test groups: test substance
- Control group: test substance
- Site: virgin test site, laterally on the right rear quadrant of the exposure area
- Concentrations: 100%, moistened with deionised water
- Evaluation (hr after challenge): 24, 48
Challenge controls:
yes
Positive control substance(s):
yes
Remarks:
1-Chloro-2,4-dinitrobenzene

Results and discussion

Positive control results:
positive reaction in 10/10 animals after 24 h and in 4/10 animals after 48 h

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1% w/v solution in acetone
No. with + reactions:
10
Total no. in group:
10

Any other information on results incl. tables

No skin irritation was observed after 24 or 48 h in the irritation screening test at any concentration level. Body weight gain in the treated group was comparable to the negative control group.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
C16 Alkylamidopropyltrimethylammonium Chloride was not sensitising in this dermal sensitisisation study in guinea pig using the Buehler method.
Executive summary:

In a dermal sensitisation study comparable to OECD guideline 406 (17 July 1992) with C16 Alkylamidopropyltrimethylammonium Chloride (97.8% a.i.) 10 young adult Hartley guinea pigs were tested using the method of Buehler.

Test concentrations were selected based on the results of an irritation screening study: neither of the concentrations used in the pretest (100%, 75%, 50% and 25% w/v concentrations of the test substance in deionised water) produced skin irritation. Thus, in the main study 400 mg of the test substance moistened with 300 µL deionized water were used for epicutaneous induction and challenge.

After challenge no visible changes of the treated skin sites were observed in the test and control group animals 24 and 48 h after patch removal (= grade 0).

The positive control 1-Chloro-2,4-dinitrobenzene produced a sensitisation rate of 100%.

The test material produced a response in 0% of animals. According to CLP, EU GHS (Regulation (EC) No 1272/2008), a response of at least 15% of the test animals of an non-adjuvant type guinea pig test method for skin sensitisation is considered as positive.

C16 Alkylamidopropyltrimethylammonium Chloride is not a dermal sensitiser in this study.