Registration Dossier
Registration Dossier
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EC number: 412-260-6 | CAS number: 52658-19-2 MONO 442
Skin sensitisation
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:
- other: Data provided by ECHA on request of Cytec Surface Specialties NV/SA. SNIF last update on 1993-10-25, UUID: SNIF-a53a2718-53ed-33b4-b9a3-440eef4897f2
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC (Magnusson and Kligman)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted before the requirement for LLNA as a basic study to perform was mandated in 2013.
Test material
- Reference substance name:
- A mixture of: 7,9,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecane-1,16-diylprop-2-enoate; 7,7,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecan-1,16-diylprop-2-enoate
- EC Number:
- 412-260-6
- EC Name:
- A mixture of: 7,9,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecane-1,16-diylprop-2-enoate; 7,7,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecan-1,16-diylprop-2-enoate
- Cas Number:
- 52658-19-2
- Molecular formula:
- C21H34N2O8 (molecular formula of the two isomers constituting the substance)
- IUPAC Name:
- 2-({[(2R)-2,4,4-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate; 2-({[(2S)-2,4,4-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate; 2-({[(3R)-3,5,5-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate; 2-({[(3S)-3,5,5-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate; 2-({[2,2,4-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate; 2-({[2,4,4-trimethyl-6-({[2-(prop-2-enoyloxy)ethoxy]carbonyl}amino)hexyl]carbamoyl}oxy)ethyl prop-2-enoate
- Details on test material:
- - Substance type: Very viscous clear yellowish liquid
- Physical state: liquid
- Analytical purity: >=95%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: not stated
- Age at study initiation: not stated
- Weight at study initiation: not stated
- Housing: not stated
- Diet (e.g. ad libitum): not stated
- Water (e.g. ad libitum): not stated
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not stated
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light):not stated
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: semi-liquid paraffin
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a). Intradermal 5% in semi-liquid paraffin
b). Topical 100%
Concentration of test material and vehicle used for each challenge:
a). 100%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: semi-liquid paraffin
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a). Intradermal 5% in semi-liquid paraffin
b). Topical 100%
Concentration of test material and vehicle used for each challenge:
a). 100%
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Maximum concentration not causing irritating effect in a preliminary test was 100%.
Signs of irritation during induction: slight erythema was observed at application sites, treated with the vehicle alone, for up to 3 days and at sites treated with the test substance in vehicle, up to 5 days after application.
Evidence of sensitisation for each challenge concentration:
- 1st challenge: 4 out of 10,
- 2nd challenge: 8 out of 10
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Conclusions:
- Under the study conditions, the test substance was sensitising to guinea pig skin.
- Executive summary:
A study was conducted to determine skin sensitization potential of the test substance to guinea pig according to the method described in EC Regulation 92/69/EEC. Pirbright white guinea pigs were used in the skin sensitisation study. The concentration of the test substance and vehicle tested in the induction and challenge was 5% in semi-liquid paraffin. Intradermal injections of the test substance caused well defined erythema and slight oedema at the test sites of more than 30% animals. Under the study conditions, the test substance was sensitising to guinea pig skin (Anonymous, 1993).
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