Registration Dossier
Registration Dossier
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EC number: 263-214-5 | CAS number: 61792-11-8
Specific investigations: other studies
Administrative data
- Endpoint:
- phototoxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1 March 1983 to 3 March 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The objective of the study was to determine the phototoxic potential of Lemonile to the skin in guinea pigs.
- GLP compliance:
- no
- Type of method:
- in vivo
Test material
- Reference substance name:
- (2Z/6Z)-3,7-dimethylnona-2,6-dienenitrile
- Molecular formula:
- C11H17N
- IUPAC Name:
- (2Z/6Z)-3,7-dimethylnona-2,6-dienenitrile
- Reference substance name:
- (2Z/6E)-3,7-dimethylnona-2,6-dienenitrile
- Molecular formula:
- C11H17N
- IUPAC Name:
- (2Z/6E)-3,7-dimethylnona-2,6-dienenitrile
- Reference substance name:
- (2E/6Z)-3,7-dimethylnona-2,6-dienenitrile
- Molecular formula:
- C11H17N
- IUPAC Name:
- (2E/6Z)-3,7-dimethylnona-2,6-dienenitrile
- Reference substance name:
- (2E/6E)-3,7-dimethylnona-2,6-dienenitrile
- Molecular formula:
- C11H17N
- IUPAC Name:
- (2E/6E)-3,7-dimethylnona-2,6-dienenitrile
- Reference substance name:
- (3E/6Z)-3,7-dimethylnona-3,6-dienenitrile
- Molecular formula:
- C11H17N
- IUPAC Name:
- (3E/6Z)-3,7-dimethylnona-3,6-dienenitrile
- Reference substance name:
- (3E/6E)-3,7-dimethylnona-3,6-dienenitrile
- Molecular formula:
- C11H17N
- IUPAC Name:
- (3E/6E)-3,7-dimethylnona-3,6-dienenitrile
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
impurity 1
impurity 2
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan white spotted
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute Biological Research, Füllinsdorf, Switzerland
- Weight at study initiation: 300 - 450 g
- Housing: Wire mesh cages
- Diet: Pellet standard NAFAG No. 844, CH-9202, Switzerland
- Water: tap water available ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 45 ± 10%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hours light per day
- Light source: UV-lamp Westinghouse FS 40 "Black Lamp", energy 10⁴ ergs/cm2/s , spectrum 320 nm - 400 nm wavelength, giving a radiation dose of 20 J/cm²
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- DMSO
- Details on exposure:
- INDUCTION PHASE
Both flanks of 10 guinea pigs were shaved by electric clippers at a minimum of 2 hours before the chemical was applied to the test site. Thereafter, a maximum of 5 test sites of 2 cm2 were marked on both flanks by circular stamp. To 4 test areas the test material was applied and the fifth test site was treated with a 0.1% alcoholic solution of 8MOP and serves as a control.
Thirty minutes after application of the test material the left flank of experimental animals was exposed to non-erythemogenic UV-A irradiation. The test sites on the right flanks remain unexposed after treatment and serve as control sites.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10% test material plus 2% DMSO
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 animals
- Control animals:
- yes, concurrent no treatment
Examinations
- Examinations:
- Reading and grading of skin responses was performed 4, 24 and 48 hours after application of the test material for signs of erythema and edema.
- Scoring system:
-- 0. No reaction
-- 1. Defined erythema
-- 2. Erythema and defined oedema
-- 3. Marked erythema and oedema - Positive control:
- 8 MOP
Results and discussion
- Details on results:
- See Table 1
Any other information on results incl. tables
Table 1:Results data
Animals |
Left flank: irradiated with 20 J UV-A/cm2 |
Right flank: no irradiation (controls) |
||||||||||
Treated with test material |
Treated with 0.1% 8 MOP |
Treated with test material |
Treated with 0.1% 8 MOP |
|||||||||
Reading of reactions |
Reading of reactions |
Reading of reactions |
Reading of reactions |
|||||||||
4 h |
24 h |
48 h |
4 h |
24 h |
48 h |
4 h |
24 h |
48 h |
4 h |
24 h |
48 h |
|
1-10 |
0 |
0 |
0 |
1 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
Grading scale: 0 = no reaction
1 = slight reaction
2 = well-defined reaction
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions used, Lemonile showed no photoxic potential.
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