Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Not sensitizing based on read across to C12 -14 analogue.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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
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.
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
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5%
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
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
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.
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.

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.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Both the source and target substances are UVCB alkyldimethyl betaines. The Source substance has an alkyl chain length distribution comprising mainly C12-14, whilst the target chain length distribution is C12-16. It is considered that the presence of a greater percentage of C16 chain lengths in the target will not affect the skin sensitisation potential of the substance compared to the C12-14 source.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: betaines, C12-14 (even numbered) -alkyldimethyl [EC 931-700-2] C-chainlengths: ≤ C10: max. 4%; C12: 65-75%; C14: 22-28%; ≥ C16: max. 8%
Target: betaines, C12-16 (even numbered) -alkyldimethyl [EC 947-036-1, CAS n/a]. Composition information per section 1.2

3. ANALOGUE APPROACH JUSTIFICATION


4. DATA MATRIX
Source: betaines, C12-14 (even numbered) -alkyldimethyl [EC 931-700-2]: not sensitising (OECD TG 406)
Target: betaines, C12-16 (even numbered) -alkyldimethyl [EC 947-036-1, CAS n/a]: no data
Reason / purpose for cross-reference:
read-across source
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on test data available from an OECD TG 406 study for the C12 -14 analogue, the substance is not sensitising and classification is not required.