Ethylcyclohexane

Endpoint summary

Description of key information

Acute eye irritation in vivo:

After administration of a single dose of 0.1 mL of the test material into the conjunctival sac of one eye of each animal, three of the six eyes were washed with distilled water. The remaining three eyes were not irrigated. Signs of irritation in unwashed eyes and washed eyes were limited to slight erythema of the conjunctivae and nictitating membranes one hour after administration of the test material. At the time of examinations on the day following dosing, all eyes in both groups (unwashed and washed) appeared clinically normal. When unwashed and washed eyes were tested with fluorescein dye 24 hours after administration of the test material, corneal and adnexal staining were not evident. No other signs of irritation were noted during the 72-hour observation period. Immediate irrigation of the eyes had no effect on the minimal irritation responses

observed. No non-ocular effects were noted for unwashed or washed eyes during the observation period.

Based on the minimal irritant responses observed in unwashed and washed eyes, the material was classified as "not irritating to eyes".

Acute skin irritation in vivo:

A dose of 0.5 mL of the test material was applied to the skin after the hair was removed with an electric clipper. An occlusive wrap was used to hold the test material against the skin for a period of four hours. No signs of irritation or abnormal clinical signs were observed at any time during the study. All animals survived the 14-day observation period, and all gained weight normally. Based on weight gain and survival rate, there was no evidence of percutaneous absorption.

Based on the lack of an irritant response, the test material was classified as "not irritating to skin".

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:

1992-01-14 - 1992-03-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: Hra:(NZW)SPF

Details on test animals or test system and environmental conditions:

Source: Hazleton Research Laboratories, Denver, PA, USA
No. of Animals: 3
Sex: Not Determined
Body Weight Range at Dosing (grams): 3477 - 3572
Age: Young Adults (At least three months old)
Housing:
All animals were individually housed in suspended, stainless-steel, mesh cages.
Environmental Conditions:
A photoperiod of 12 hours light from 6 a.m. to 6 p.m. Room temperature was maintained at 70-74°F. Relative humidity was maintained at 41-52%.
Diet andWater: ad libitum

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 mL/animal

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

The hair was removed from an area of the dorsal skin with an electric clipper. A single dose of the material was placed in contact with the sin using a fiber pad and an occlusive wrap to hold the test material in place for four hours. At the end of the exposure period, the application site was rinsed with running water.
The site of application was examined at 1, 24, 48 and 72 hours, and 7 and 14 days after removal of the occlusive patch. Observations included estimation of erythema, edema, necrosis, eschar formation, scarring, erosion, and staining caused by the material as well as general systemic effects.
Animals were weighed at initiation of the study (Day 0), on Day 7, and at termination of the 14-day observation period.No necropsies were conducted at the conclusion of the 14-day observation period.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Clinical observations graded as described in OECD Guideline 404 (erythema, edema)

ANIMAL NUMBER	DOSE <mL)	RESPONSE AT THE SITE OF APPLICATION
		1HOUR	24HOURS	48HOURS	72HOURS	7DAYS	14DAYS
797	0.5	0,0	0,0	0,0	0,0	0,0	0,0
798	0.5	0,0	0,0	0,0	0,0	0,0	0,0
799	0.5	0,0	0,0	0,0	0,0	0,0	0,0

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the lack of an irritant response, the test material was classified as "not irritating to skin".

Executive summary:

A dose of 0.5 mL of the test material was applied to the skin after the hair was removed with an electric clipper. An occlusive wrap was used to hold the test material against the skin for a period of four hours. No signs of irritation or abnormal clinical signs were observed at any time during the study. All animals survived the 14-day observation period, and all gained weight normally. Based on weight gain and survival rate, there was no evidence of percutaneous absorption.

Based on the lack of an irritant response, the test material was classified as "not irritating to skin".

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:

1992-01-21 - 1992-03-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SRID or Lot I.D. Number: 7482-9A
Physical State and Appearance: Colorless liquid

Species:

rabbit

Strain:

other: Hra:(NZW)SPF

Details on test animals or tissues and environmental conditions:

Source: Hazleton Research Animals, Denver, PA, USA
No. of Animals: 6; 3 Washed/3 Unwashed
Sex: Not Determined
Body Weight Range at Dosing: Not Determined
Age: Young Adults (At least three months old)
Housing:
All animals were individually housed in suspended, stainless-steel, mesh cages.
Environmental Conditions:
A photoperiod of 12 hours light from 6 am. to 6 p.m. Room temperature was maintained at
70-74°F. Relative humidity was maintained at 48-51%
Diet and Water: ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0. 1 mL/eye

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

Both eyes of each rabbit selected for the study were tested with fluorescein dye and examined within 24 hours of administering the test material. Animals showing eye irritation, ocular defects, or pre-existing corneal injury were not used.
A single dose of the material was placed into the conjunctival sac of one eye of each animal. Three of the eyes were immediately washed with running distilled water; the other three eyes were not irrigated.
Clinical Observations:
Eyes were observed immediately after instillation of the test material and 1, 24, 48, and 72 hours thereafter. Observations included indications of immediate sensory irritation and estimations of edema and erythema of the cornea and adnexal structures. Also evaluated were effects on the iris, the presence of corneal opacity and/or discharge from the eye. Eyes were treated with a 2% ophthalmic solution of fluorescein at 24 hours and observed for staining.
Body Weight Determinations:
Animals were not weighed as weights are not critical to this study.
Necropsy:
No necropsies were conducted at the conclusion of the test.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

not specified

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Description of Other Serious Ocular Lesions. Including Fluorescein Staining No other serious ocular lesion was noted during the study. Corneal and adnexal staining were not evident when unwashed and washed eyes were tested with fluorescein dye 24 hours after administration of the test material. Description of Non-Ocular Effects

No non-ocular effects were observed.

ANIMAL NUMBER	IRRIGATED	EFFECTS (Corneal Opacity,Iris Effects,Erythema,Chemosis)
		1Hour	24Hours	48Hours	72Hours
803	No	0,0,1,0	0,0,0,0	0,0,0,0	0,0,0,0
804	No	0,0,1,0	0,0,0,0	0,0,0,0	0,0,0,0
805	No	0,0,0,0	0,0,0,0	0,0,0,0	0,0,0,0
806	Yes	0,0,1,0	0,0,0,0	0,0,0,0	0,0,0,0
807	Yes	0,0,1,0	0,0,0,0	0,0,0,0	0,0,0,0
808	Yes	0,0,1,0	0,0,0,0	0,0,0,0	0,0,0,0

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the minimal irritant responses observed in unwashed and washed eyes, the material was classified as "not irritating to eyes"

Executive summary:

After administration of a single dose of 0.1 mL of the test material into the conjunctival sac of one eye of each animal, three of the six eyes were washed with distilled water. The remaining three eyes were not irrigated. Signs of irritation in unwashed eyes and washed eyes were limited to slight erythema. of the conjunctivae and nictitating membranes one hour after administration of the test material. At the time of examinations on the day following dosing, all eyes in both groups (unwashed and

washed) appeared clinically normal. When unwashed and washed eyes were tested with fluorescein dye 24 hours after administration of the test material, corneal and adnexal staining were not evident. No other signs of irritation were noted during the 72-hour observation period. Immediate irrigation of the eyes had no effect on the minimal irritation responses

observed. No non-ocular effects were noted for unwashed or washed eyes during the observation period.

Based on the minimal irritant responses observed in unwashed and washed eyes, the material was classified as "not irritating to eyes"

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Acute eye irritation:

The respective criteria are not met. Ethylcyclohexane has not to be classified for eye irritation.

Acute skin irritation:

The respective criteria are not met. Ethylcyclohexane has not to be classified for skin irritation.