Reaction mass of (E)-3,7-dimethylocta-2,6-dien-1-yl formate and 3,7-dimethyloct-6-en-1-yl formate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 1972

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:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

study pre-dates introduction of GLP

Test material

Test material information

Constituent 1

Reference substance name:

Geranyl formate

EC Number:

203-339-4

EC Name:

Geranyl formate

Cas Number:

105-86-2

Molecular formula:

C11H18O2

IUPAC Name:

(E)-3,7-dimethylocta-2,6-dien-1-yl formate

Constituent 2

Reference substance name:

Citronellyl formate

EC Number:

203-338-9

EC Name:

Citronellyl formate

Cas Number:

105-85-1

Molecular formula:

C11H20O2

IUPAC Name:

3,7-dimethyloct-6-en-1-yl formate

impurity 1

Reference substance name:

Geraniol

EC Number:

203-377-1

EC Name:

Geraniol

Cas Number:

106-24-1

Molecular formula:

C10H18O

IUPAC Name:

(E)-3,7-dimethylocta-2,6-dien-1-ol

impurity 2

Reference substance name:

Rhodinyl formate

EC Number:

205-456-6

EC Name:

Rhodinyl formate

Cas Number:

141-09-3

Molecular formula:

C11H20O2

IUPAC Name:

3,7-dimethyloct-7-en-1-yl formate

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Nerger Formate
- Lot: SA-08-1712

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.3 to 3.4 kg
- Housing: Individually housed
- Diet: Free access to commercial diets
- Water: Free access to water

Test system

Vehicle:

other: alcohol SDA 39C

Controls:

other: the other eye, remaining untreated, served as control.

Amount / concentration applied:

Each animal had 0.1ml of the test sample instilled into the right eye with no further treatment

Observation period (in vivo):

1, 4, 24, 48, 72 and 96 hours and daily thereafter for a total of seven days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize method

TOOL USED TO ASSESS SCORE: At day 7, all eyes were re-examined with the aid of fluorescein ophthalmic solution.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Remarks on result:

other: no effects were observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Remarks on result:

other: no effects were observed

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Remarks on result:

other: no effects were observed

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24 and 72 hours

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: no individual Draize scores were reported

Irritant / corrosive response data:

No lesions occurred in the cornea and iris in the animals at any time following the instillation of the test substance. Conjunctival irritation was observed at one and four hours in four out of six animals and in one animal at 24 hours. The effects were fully reversible within 72 hours.

Other effects:

No systemic toxic effects occurred.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an eye irritation study with rabbits, performed equivalent to OECD 405 test guideline, limited irritation was observed.

Executive summary:

The test substance Geranyl Formate was tested in an acute eye irritation study with rabbits, performed equivalent to OECD 405 guideline. No systemic toxic effects occurred. No lesions occurred in the cornea and iris in the animals at any time following the instillation of the test substance. Conjunctival irritation was observed at one and four hours in four out of six animals and in one animal at 24 hours. The effects were fully reversible within 72 hours. Based on the results, Geranyl Formate does not have to be classified for eye irritation according to Regulation (EC) No 1272/2008.