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Registration Dossier
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Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 30, 1979 - January 4, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to study described in Materials and methods
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- November 30, 1979 - January 4, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to study described in Materials and methods
- Justification for type of information:
- ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The structures of the target and source substances are identical and differ only with respect to the ratio of enantiomers where the target substance is a single pure L-isomer and the source substance is an equimolar mixture of L and D isomers.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The target substance, L-Citronellyl nitrile, is a mono-constituent substance (EC No. 695-909-8, CAS no. 35931-93-2).
The source substance, DL-Citronellyl nitrile, is a mono-constituent substance (EC No. 257-288-8, CAS no. 51566-62-2).
The source and target substances are both of high purity with a low concentration of impurities.
3. ANALOGUE APPROACH JUSTIFICATION
The read across hypothesis is based on structural similarity where the only difference between target and source molecules is the enantiomeric ratio. In a non-chiral environment the target and source chemicals will have identical properties but in the chiral environment of living organisms the enantiomers may possess different carcinogenicity and teratogenicity (in a chiral environment, stereoisomers might experience selective absorption, protein binding, transport, enzyme interactions and metabolism, receptor interactions, and DNA binding). Therefore, as a precaution for the developmental toxicity endpoint it is suggested that the NOAEL 250 mg/kg bw/day for L-Citronellyl nitrile is used instead of 500 mg/kg bw/day, as it is not known which form is more potent in vivo. All other endpoints are considered to be acceptable for this substance assuming that 50% of the target compound is available in the test material.
4. DATA MATRIX
Please refer to the data matrix included in the read-across justification document attached in Section 13.2. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Twelve Hartley guinea pigs, male, 294-470 grams, acclimated for 7 days, each received a series of 10 intradermal injections of the test article, in 0.1% suspension in physiological saline, over a 3 week period. Two weeks after the last injection, a challenge injection was made. Obeservations of the diameter and height (in millimiters) and color (erythema) of any reaction at the injection site were recorded 24 hours after each treatment.
- GLP compliance:
- yes
- Type of study:
- Draize test
- Justification for non-LLNA method:
- Study carried out in 1980.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 4 to 6 weeks of age
- Weight at study initiation: 294 - 470 grams
- Housing: galvanized or stainless steel cages
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: 7 days
- Indication of any skin lesions: checked upon receipt and prior to test initiation - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.05 mL
- Day(s)/duration:
- 1
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 3 weeks
- Test groups: 12 animals
- Control group: none
- Site: mid-dorsal area of the trunk, 3 or 4 centimeters square
- Duration: 3 weeks.
- Concentrations: 0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: 10 animals
- Control group: none
- Concentrations: 0.05 mL
- Evaluation: 24 hours
- Challenge controls:
- none
- Positive control substance(s):
- no
- Positive control results:
- Not applicable
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- Animal #1 - #12: No gross changes observed.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- other: not applicable
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: not applicable
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The readings at the challenge were not higher than the average readings for the 10 induction injection, the test article was not considered a sensitizer in guinea pigs.
See attachment for result tables.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Twelve Hartley guinea pigs, male, 294-470 grams, acclimated for 7 days, each received a series of 10 intradermal injections of the test article, in 0.1% suspension in physiological saline, over a 3 week period. Two weeks after the last injection, a challenge injection was made. Obeservations of the diameter and height (in millimiters) and color (erythema) of any reaction at the injection site were recorded 24 hours after each treatment.
- GLP compliance:
- yes
- Type of study:
- Draize test
- Justification for non-LLNA method:
- Study carried out in 1980.
Test material
- Reference substance name:
- 3,7-dimethyloct-6-enenitrile
- EC Number:
- 257-288-8
- EC Name:
- 3,7-dimethyloct-6-enenitrile
- Cas Number:
- 51566-62-2
- Molecular formula:
- C10H17N
- IUPAC Name:
- 3,7-dimethyloct-6-enenitrile
- Details on test material:
- name: Citronellal Nitril
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 4 to 6 weeks of age
- Weight at study initiation: 294 - 470 grams
- Housing: galvanized or stainless steel cages
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: 7 days
- Indication of any skin lesions: checked upon receipt and prior to test initiation
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.05 mL
- Day(s)/duration:
- 1
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 3 weeks
- Test groups: 12 animals
- Control group: none
- Site: mid-dorsal area of the trunk, 3 or 4 centimeters square
- Duration: 3 weeks.
- Concentrations: 0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: 10 animals
- Control group: none
- Concentrations: 0.05 mL
- Evaluation: 24 hours
- Challenge controls:
- none
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- Animal #1 - #12: No gross changes observed.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- other: not applicable
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: not applicable
Any other information on results incl. tables
See attachment for result tables.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The readings at the challenge were not higher than the average readings for the 10 induction injection, the test article was not considered a sensitizer in guinea pigs.
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