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

Endpoint summary

Description of key information

Dermal:

As part of a "Weight of Evidence Approach", three studies were assessed. A modified Draize sensitization study where a preliminary irritation screen was conducted to determine the application challenge concentration (100%). A dermal acute LD50 study dosed at 5 mL/kg and a human irritiation experiment at 2%. No irritation was noted in any of the three studies indicatin no irritation risk when exposed to geranyl formate.

Eye:

The slight irritation noted was only slightly more than for the vehicle control ( alcohol SDA 39C) and not sufficient for classification purposes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Qualifier:

according to guideline

Guideline:

other: Maximization Test (J.I.D; Vol. 47; #5; 1966)

GLP compliance:

no

Remarks:

study pre-dates GLP introducion

Specific details on test material used for the study:

Geranyl Formate

Species:

human

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: petrolatum N.F

Duration of treatment / exposure:

Each material was applied to the same skin site for five alternate-day fourty-eight hour periods under occlusion. Following a 10-day rest period, occlusive challenge patches were applied to fresh skin sites for fourty-eight hours. Challenges were evaluated at 48 and 72 hours.

Number of animals:

Twenty-five healthy adult males

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

Geranyl Formate did not produce any cases of contact allergy or irritation.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Qualifier:

no guideline available

GLP compliance:

no

Remarks:

study pre-dates GLP introduction

Specific details on test material used for the study:

CFI-70 Geranyl Formate
Colourless liquid

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

New Zealand WHite rabbits of both sexes (weighing 2.5 to 3.0 kg) were used. All animals were individually housd, commercial diets were offered, and water was available ad libitum.

Preparation of test site:

other: An area measuring approximately 240 cm2 was clipped, and the site was abraded on 2 animals while the site on the remaining 2 animals remained intact. The test site was slightly moistened with physiological saline prior to application.

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

5 ml/kg of neat test material

Observation period:

The animals were observed for irritation daily for 14 days

Number of animals:

Four rabbits of both sexes

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

No skin irritation was observed following treatment of Geranyl Formate of New Zealand White rabbits.

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Performed equivalent to OECD 406 guideline.

GLP compliance:

no

Remarks:

study pre-dates GLP introduction

Specific details on test material used for the study:

Perfume ingredient: Geranyl Formate

Species:

guinea pig

Strain:

Hartley

Details on test animals or test system and environmental conditions:

Sensitization tests were carried out on inbred Hartley strain albino guinea pigs bred in our own colony. During testing they were housed in wire mesh cages in pairs of the same sex and were fed pelleted guinea pig diet, cabbage, hay and water ad libitum. Ten animals weighing about 350 g at the start of testing were used in each test which comprised either 4 males and 6 females or visa versa. For demonstration of sensitivity by challenge with the test substance the hair was shaved from both flanks with Oster animal clippers, size 40 blades, and the test substance injected intradermally into one flank and applied topically without occlusion to the other flank.

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Number of animals:

10 animals

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

An application of Geranyl Formate was not found to be irritating to the skin of guinea pigs.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

study pre-dates introduction of GLP

Specific details on test material used for the study:

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

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

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.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Remarks on result:

other: no effects were observed

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Remarks on result:

other: no effects were observed

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Remarks on result:

other: no effects were observed

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available