Registration Dossier
Registration Dossier
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EC number: 269-084-6 | CAS number: 68187-29-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not stated
- 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:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 10 female Hartley guinea pigs were assigned to the test group and treated with an intradermal induction of 0.05 mL, 5 % test material solution in distilled water, one week later the area was re-shaved, treated with 10 % SLS solution, and then given an epidermal induction the following day. This exposure lasted for 48 hours. Two weeks after induction animals were shaved again and treated with 5 % test material solution in an occlusive challenge application that was applied for 24 hours. Five animals in the control group were also subjected to the challenge.
The challenge sites were observed 24 and hours following patch removal and the sensitising effect of the test material was evaluated. - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Adequate existing data available on the test material using GPMT method.
Test material
- Reference substance name:
- L-Glutamic acid, N-coco acyl derivs., compds. with triethanolamine (1:1)
- EC Number:
- 269-084-6
- EC Name:
- L-Glutamic acid, N-coco acyl derivs., compds. with triethanolamine (1:1)
- Cas Number:
- 68187-29-1
- Molecular formula:
- Not specified (UVCB substance)
- IUPAC Name:
- bis(tris(2-hydroxyethyl)azanium) (2S)-4-carboxy-2-dodecanamidobutanoate (2S)-4-carboxy-2-tetradecanamidobutanoate
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test material was dissolved in distilled water for injection to prepare a 5 % solution for both induction and challenge.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Housing: guinea pigs were kept five per cage in an animal-keeping room.
- Diet: Ad libitum
- Water: Ad libitum tap water
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 3 °C
- Humidity: 55 ± 15 %
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- Intradermal: 5 % / 0.05 mL
Epicutaneous: 5 % solution on cotton lint - Day(s)/duration:
- Intradermal injection on day 1, Epicutaneous application applied on Day 8 for 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- 5 % solution was applied to cotton lint
- Day(s)/duration:
- Two weeks after the completion of induction, the occlusive challenge was applied for 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Test material group: 10 animals
Control group: 5 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
-The hair of the guinea pigs was shaved with electric hair clippers and an electric shaver on the scapular region.
-0.05 mL of each of the following substances was intradermally administered to sites (1), (2) and (3), by intradermal induction:
Emulsion of Freund's Complete Adjuvant and physiological saline,
Test material
Emulsion of Freund's Complete Adjuvant and the test material.
- The hair of the guinea pigs was shorn in the same area approximately one week following intradermal injection. 10 % SLS petroleum jelly was applied to the area.
- On the following day, the test solution was applied to cotton lint, and the cotton lint was applied to the shorn area and attached for 48 hours using tape (occlusive application: epidermal induction).
B. CHALLENGE EXPOSURE
- The hair of the guinea pigs was shaved lower on the back approximately two weeks following completion of induction. On the following day, the test solution was applied to cotton lint, and the cotton lint was applied to the test site and attached for 24 hours using tape (occlusive application: challenge).
- Skin reactions were examined 24 and 48 hours following patch removal in accordance with the scoring system shown below to evaluate the sensitising effect of the test material:
0: No reaction
1: Mild or scattered erythema
2: Moderate and diffuse erythema
3: Intense erythema and swelling
-The control group was also treated from the challenge stage onwards. - Challenge controls:
- The control animals were untreated in the induction stage but were treated with an occlusive challenge application treatment of the test material alongside the test group animals.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- 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 chemical
- Dose level:
- 5 %
- 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:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
No abnormality was observed in the test article group or the control group following the challenge.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria.
- Conclusions:
- Under the conditions of this study, the test material was not considered to be a skin sensitiser.
- Executive summary:
The potential of the test material to be a skin sensitiser was investigated in a guinea pig maximisation test.
10 female Hartley guinea pigs were assigned to the test group and treated with an intradermal induction of 0.05 mL, 5 % test material solution in distilled water, one week later the area was re-shaved, treated with 10 % SLS solution, and then given an epidermal induction the following day. This exposure lasted for 48 hours. Two weeks after induction animals were shaved again and treated with 5 % test material solution in an occlusive challenge application that was applied for 24 hours. Five animals in the control group were also subjected to the challenge.
The challenge sites were observed 24 and hours following patch removal and the sensitising effect of the test material was evaluated.
No abnormalities were observed in the test or control group following the challenge. No skin reactions were observed in any animal at 24 or 48 hours.
Under the conditions of this study, the test material was not considered to be a skin sensitiser.
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