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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1983
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

Constituent 1
Chemical structure
Reference substance name:
(2Z/6Z)-3,7-dimethylnona-2,6-dienenitrile
Molecular formula:
C11H17N
IUPAC Name:
(2Z/6Z)-3,7-dimethylnona-2,6-dienenitrile
Constituent 2
Chemical structure
Reference substance name:
(2Z/6E)-3,7-dimethylnona-2,6-dienenitrile
Molecular formula:
C11H17N
IUPAC Name:
(2Z/6E)-3,7-dimethylnona-2,6-dienenitrile
Constituent 3
Chemical structure
Reference substance name:
(2E/6Z)-3,7-dimethylnona-2,6-dienenitrile
Molecular formula:
C11H17N
IUPAC Name:
(2E/6Z)-3,7-dimethylnona-2,6-dienenitrile
Constituent 4
Chemical structure
Reference substance name:
(2E/6E)-3,7-dimethylnona-2,6-dienenitrile
Molecular formula:
C11H17N
IUPAC Name:
(2E/6E)-3,7-dimethylnona-2,6-dienenitrile
impurity 1
Chemical structure
Reference substance name:
(3E/6Z)-3,7-dimethylnona-3,6-dienenitrile
Molecular formula:
C11H17N
IUPAC Name:
(3E/6Z)-3,7-dimethylnona-3,6-dienenitrile
impurity 2
Chemical structure
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

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.