Octanal

Endpoint summary

Description of key information

Octanal was shown to be a skin and eye irritant in modern guideline-compliant studies in the rabbit.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 December 1993 to 20 December 1993.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Not relevant

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield (U, K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 11 to 13 weeks of age
- Weight at study initiation: 2.4 to 3.0 kg
- Housing: Housed individualIy In metal cages with perforated floors
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: Animals were acclimatised but no indication of length of acclimatisation.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19°C
- Humidity (%): 30 -70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light and 12 hours dark

IN-LIFE DATES: From: 7 December 1993 to 20 December 1993

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: An area approximately 100 x 100mm was shaved on the dorso-lumbar region of each rabbit. a 25 x 25 mm test site within this area was used for application
- % coverage: Not documented
- Type of wrap if used: Semi-occlusive Elastoplast elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treatment site was washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: Immediately after bandage removal at the end of the 4 h exposure period

Reactions were scored according to a modified Draize system:
SCORING SYSTEM:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth)
preventing erythema reading 4

Oedema formation:
No oedema o Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than I millimetre and extending beyond the area of exposure) 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 4 hours

Score:

1.6

Max. score:

2

Reversibility:

no data

Remarks on result:

other: Some blanching and hardening of the skin was observed.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 4 hours

Score:

2

Max. score:

3

Reversibility:

no data

Remarks on result:

other: Some necrosis, blanching of the skin, hardening of the skin and new skin formation was observed.

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 4 hours

Score:

2.1

Max. score:

3

Reversibility:

no data

Remarks on result:

other: Some blanching and hardening of the skin was observed.

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 4 hours

Score:

1.1

Max. score:

2

Reversibility:

no data

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 4 hours

Score:

1.3

Max. score:

3

Reversibility:

fully reversible

Remarks:

12 days

Remarks on result:

other: Some hardening of the skin was observed on Day 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 4 hours

Score:

2.1

Max. score:

3

Reversibility:

fully reversible

Remarks:

13 days

Remarks on result:

other: Some hardening of the skin was observed on days 8, 9 and 10.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: erythematous reactions persisted in all three rabbits at termination after 14 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.44

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: reactions were reversible in only two of three rabbits. Oedema was present for all three until 11 days after dosing

Irritant / corrosive response data:

Well-defined to moderate erythema with slight to moderate oedema developed in all three animals and was accompanied by blanching and hardening of the skin. These reactions gradually ameliorated and new skin was seen on one animal from day 12. The erythematous reactions persisted to termination in all three treated rabbits.

Other effects:

No additional information provided

Dermal Reactions observed following application of Aldehyde C8

Rabbit number

E=Erythema O=Oedema

Day

1*

2

3

4

5

6

7

8

9

10

11

12

13

14

1

E O

2 2

b2 2

b2 1

b2 1

b2 1

b2 1

b2 1

b2 1

c2 1

c1 1

c1 1

c1 1

c1 1

c1 1

2

E O

a1 1

b2 1

b2 1

b2 1

b2 1

c3 2

b3 c2

c3 2

c3 2

c2 2

c2 2

d1 0

d1 0

d1 0

3

E O

2 2

b2 2

b2 2

b2 2

b3 3

b3 3

b3 3

b3 c3

b2 c3

b2 c2

c2 2

c2 2

c1 0

c1 0

* Approximately 30 minutes after removal of the dressing

a Necrotic edge

b Blanching

c Hardening of the skin

d New skin.

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the test substance Aldehyde C8 was considered to be irritating to intact rabbit skin.

Executive summary:

In a study conducted in 1994, the test substance Aldehyde C8 was examined for its ability to cause skin irritation when tested on intact rabbit skin. The dorso-lumbar regions of each animal were shaved approximately 24 hours prior to the start of the study. 0.5 mL of undiluted test substance was applied under a gauze pad to one intact skin site on each animal and a semi-occlusive dressing was applied over it. The dressing was left in place for 4 hours before being removed and the test area wiped clear of any residual test substance. The skin reactions of each test animal were observed for 14 days. Well-defined to moderate erythema with slight to moderate oedema developed in all three animals and was accompanied by blanching and hardening of the skin. These reactions gradually ameliorated and new skin was seen on one animal after 12 days. Under the conditions of this study, the test substance Aldehyde C8 was considered to be irritating to intact rabbit skin. Based on these results, the test substance should be classified as a Category 2 skin irritant and should have the signal word Warning and the hazard statement H315: Causes skin irritation associated with it in accordance with Regulation EC No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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:

20 December 1993 to 18th January 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline and GLP compliant study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Principles of method if other than guideline:

Not relevant

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield (U .K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 13 to 15 weeks of age
- Weight at study initiation: 2.9 to 3.6 kg
- Housing: Housed individually in plastic cages with perforated floors.
- Diet (e.g. ad libitum): Standard laboratory diet SDS Stanrab (P) Rabbit Diet ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: The rabbits were acclimatised but the period of acclimatisation is not specified in the study report.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): Approximately 19 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours artificial light (0700 - 1900) and 12 hours dark

IN-LIFE DATES: From: 20 December 1993 To: 18 January 1994

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated contralateral eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume): 0.1ml

Duration of treatment / exposure:

14 days

Observation period (in vivo):

14 days.
All animals were observed daily for signs of ill health or toxicity. Examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4, 7 and 14 days after instillation.

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No information provided to indicate treated eyes were rinsed after instillation

SCORING SYSTEM: Modified Draize assessment
Cornea :
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre),
details of iris clearly visible 1
Easily discernible transIucent areas, details of iris slightly obscured 2
Nacreous areas. no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4

Iris:
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or
injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2

Conjunctivae:
Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis (lids and/or nictating membranes)
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Dulling of the cornea was observed one hour after administration

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: No effects observed on the iris

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

ca. 1.6

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Dulling of the corneas was observed 1 hour after administration

Irritation parameter:

iris score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Dulling of the cornea was observed one hour after administration

Irritation parameter:

iris score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: No effects observed on the iris

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2.11

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.89

Max. score:

4

Irritant / corrosive response data:

Corneal opacities developed in two animals. Dulling of the normal lustre of the cornea was seen in one animal. Iridial inflammation was observed in one animal.
A diffuse crimson colouration of the conjunctivae was seen in all three animals and was accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed. The eyes had returned to normal 7 or 14 days after instillation

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Ocular Reactions observed after instillation of Aldehyde C8:

Rabbit	Region of the eye		One hour	Day after instillation
				1	2	3	4	7	14
1*	Cornea		D	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctivae	Redness	2	2	2	2	1	0
		Chemosis	3	2	1	1	1	0
2	Cornea		D	1	1	1	1	1	0
	Iris		0	1	0	1	1	0	0
	Conjunctivae	Redness	2	3	2	2	2	2	0
		Chemosis	3	3	2	2	1	1	0
3	Cornea		D	1	1	1	1	0	0
	Iris		0	0	0	0	0	0	0
	Conjunctivae	Redness	2	2	2	2	2	2	0
		Chemosis	3	2	2	2	2	1	0

* Pilot Animal

D Dulling

Interpretation of results:

Category 2A (irritating to eyes)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the test substance Aldehyde C8 was determined to be irritating when tested in rabbit eyes.

Executive summary:

In a study conducted in 1994, the potential of the test substance Aldehyde C8 to cause irritation to the eyes was determined in rabbits. Three New Zealand White rabbits were administered a single ocular dose of 0.1 mL of the test substance undiluted and they were observed for 14 days after instillation. The test substance was administered into one eye of each rabbit with the other eye remaining as the untreated control. Following application, the treated eye elicited corneal opacity. iridial inflammation and well-defined conjunctival irritations. However, all reactions had resolved by14 days after instillation.

Under the conditions of this study, the test substance Aldehyde C8 was determined to be irritating when tested in rabbit eyes. Based on these results, the test substance should be classified as a Category 2 eye irritant according to Regulation EC No. 1272/2008.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation/Corrosion

In a study conducted in 1994, the test substance Aldehyde C8 (octanal) was examined for its ability to cause skin irritation when tested on intact rabbit skin. The dorso-lumbar regions of each animal were shaved approximately 24 hours prior to the start of the study. 0.5ml of undiluted test substance was applied under a gauze pad to one intact skin site on each animal and a semi-occlusive dressing was applied over it. The dressing was left in place for 4 hours before being removed and the test area wiped clear of any residual test substance. The skin reactions of each test animal were observed for 14 days. Well-defined to moderate erythema with slight to moderate oedema developed in all three animals and was accompanied by blanching and hardening of the skin. These reactions gradually ameliorated and new skin was seen on one animal. The reactions persisted to termination with some indications of reversibility. Under the conditions of this study, the test substance Aldehyde C8 was considered to be irritating to intact rabbit skin

Eye Irritation/Corrosion

In a study conducted in 1994, the potential of the test substance Aldehyde C8 to cause irritation to the eyes was determined in rabbits. Three New Zealand White rabbits were administered a single ocular dose of 0.1ml of the test substance undiluted and they were observed for 14 days after instillation. The test substance was administered into one eye of each rabbit with the other eye remaining as the untreated control. Following application, the treated eye elicited corneal opacification, iridial inflammation and well-defined conjunctival irritations. However, all reactions had resolved 7 or 14 days after instillation. Under the conditions of this study, the test substance Aldehyde C8 was determined to be irritating when tested in rabbit eyes. Based on these results, the test substance should be classified as a Category 2 eye irritant according to Regulation EC No. 1272/2008.

Justification for selection of skin irritation / corrosion endpoint:

Only one study available for this endpoint

Justification for selection of eye irritation endpoint:

Only one study available for this endpoint

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the results of the available studies, octanal is classified as a skin irritant (Cat.2) and an eye irritant (Cat. 2) according to eth CLP Regulation.