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Diss Factsheets

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Rechallenge 2 weeks after primary challenge
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
Rechallenge 2 weeks after primary challenge
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
Test was performed before LLNA became mandatory.

Test material

Constituent 1
Chemical structure
Reference substance name:
Betaines, C12-14 (even numbered)-alkyldimethyl
EC Number:
931-700-2
Molecular formula:
C16H33NO2C18H37NO2
IUPAC Name:
Betaines, C12-14 (even numbered)-alkyldimethyl
Test material form:
other: aqueous formulation
Details on test material:
- Name of test material (as cited in study report): Genagen LAB, Hoe S 3838- Substance type: surfactant- Physical state: colourless liquid- Analytical purity: 30% in water- Composition of test material, percentage of components: Free amine: max. 0.5%; sodium chloride 7-8%- Lot/batch No.: DEGE 069380- Expiration date of the lot/batch: January 2005; stable under storage conditions- Stability under test conditions: stable for at least 100 days in water at room temperature- Storage condition of test material: In the original container, at room temperature (range of 20 ± 3 °C), away from direct sunlight- Other: C-chainlengths: ≤ C10: max. 4%; C12: 65-75%; C14: 22-28%; ≥ C16: max. 8%

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan spotted (Ibm: GOHI)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: RCC Ltd, Laboratory Animal Services, Fuellinsdorf, Switzerland- Age at study initiation: 5-8 weeks- Weight at study initiation: 346-432 g- Housing: Individually- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418, batch no. 28/03, guinea pig breeding/maintenance diet, containing Vitamin C (Provimi Kliba Ag, Kaiseraugst, Switzerland), ad libitum- Water (e.g. ad libitum): Community tap water from Fuellinsdorf, ad libitum- Acclimation period: 2 weeksENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 3- Humidity (%): 30 - 70- Air changes (per hr): 10 - 15 - Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5%
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1 %
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1 %
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Test group: 20 females, Control group: 10 females
Details on study design:
RANGE FINDING TESTS: Two irritation screening tests were performed to determine the appropriate test substance concentrations for induction and challenge. Patching was performed in the same way as in the actual test. The following concentrations were tested: 100, 75, 50, 25 % (Irritations screening I). As the skin of these animals was seriously burnt at all concentrations, and they had to be killed in extremis, a second screening with 5, 3, 1 and 0.3 % (Irritation screen II) was performed. The most representative concentration to stimulate a state of immune hypersensitivity was 5 % used in the induction phase. The highest non-irritating concentration for the challenge was determined as the concentration of 1 % in purified water.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 2 weeks
- Test group: test substance
- Control group: untreated
- Site: left shoulder
- Frequency of applications: once per week (first application on d 0)
- Duration: for 6 hours each
- Concentrations: 5% in purified water
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 29 and 43
- Test group: test substance
- Control group: test substance
- Site: 1st challenge (test and control group): left posterior quadrant of the side and back (2 patches); rechallenge (test group): right flank- Concentrations: 1% in purified water
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patches
Challenge controls:
Actually the control group was a challenge control, as the animals had not been treated in any way during the induction phase.
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde

Results and discussion

Positive control results:
Twenty (at the 24-hour reading) and 19 (at the 48-hour reading) out of 20 test animals were observed with discrete/patchy to moderate/confluent eythema after the challenge treatment with the highest non-irritating concentration of alpha-hexylcinamaldehyde at 5 % in PEG 300. No skin effect was observed in the control group.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
Discrete/patchy erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: Discrete/patchy erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
Discrete/patchy erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: Discrete/patchy erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reactions.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reactions.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Moderate/confluent erythema
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Moderate/confluent erythema.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Moderate/confluent erythema in one, discrete/patchy erythema in another animal
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Moderate/confluent erythema in one, discrete/patchy erythema in another animal.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5%
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
Discrete/patchy to moderate/confluent erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 5%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: Discrete/patchy to moderate/confluent erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
5%
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
Discrete/patchy to moderate/confluent erythema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 5%. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: Discrete/patchy to moderate/confluent erythema.

Any other information on results incl. tables

There were no deaths during the course of the study.

No symptoms of systemic toxicity were observed in the animals.

No skin effects were observed in the first and second induction week. In the third week of induction, discrete/patchy to moderate confluent erythema (grade 1 and 2) were observed in 12/20 test animals after treatment with the test item at 5 % in purified water.

Conclusion:

According to the criteria of OECD Guideline 406 Skin Sensitisation the test substance does not have to be considered as sensitising to the skin in a non-adjuvant test system.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information