Hydrocarbons, C12-C16, n-alkanes, isolkanes, alkenes

Endpoint summary

Description of key information

Available read-across data support the conclusion that the registered substance is not irritating for skin or eye.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: USEPA Pesticide Assessment Guidelines (540/9-82-025)

Deviations:

not specified

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

100%

Duration of treatment / exposure:

4 hours

Observation period:

21 days

Number of animals:

6

Details on study design:

The study was conducted on six New Zealand White rabbits, 3 male and 3 female, to determine the skin irritation potential of the test material. The animals were individually housed, equilibrated in the laboratory, and released from quarantine prior to testing. Normal growth, appearance, and behavior during the equilibration period were factors used to select healthy animals for testing.

Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to expose an area at least eight centimeters by eight centimeters. Care was taken to avoid abrading the skin. Only those animals with exposure areas free from pre-existing skin irritation or defects were selected for testing.

There was one intact skin test site per animal. East test site was treated with 0.5 milliliters of actual undiluted test material by introducing the test material at room temperature beneath a surgical gauze patch measuring 1 inch x 1 inch and two single layers thick. Each patch was secured in place with a strip of a non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) to retard evaporation of volatile substances and to prevent the animals from possibly ingesting any of the test material. To secure the wrappings in place, the edges of the dressing were wrapped with a non-irritating adhesive tape in a manner which would not cdause discomfort to the animals. The animals were then returned to their cages.

Four hours after treatment the wrapping, tape, and gause patches were removed. The backs of the animals were gently washed with room temperature tap water and a wet cloth to remove as much residual test material as possible. The animals were observed for erythema and eschar formation, edema formation, and any other dermal defects or irritation at 0, 24, 48, and 72 hours and on Days 7, 9, 13, 17, and 20 (Day 0 considered day of treatment) after washing.

For each observation time, all of the erythema and edema scores were added, and the sum was divided by the number of animals observed to determine an irritation score. The maximum irritation score was selected from the observation time yielding the highest irritation score.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 1 hr

Score:

ca. 0 - 4.2

Max. score:

4.2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 9 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 9 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 17 days

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.6

Max. score:

2

Reversibility:

fully reversible within: 9 days

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 17 days

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 20 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 9 days

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 9 days

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 9 days

Irritant / corrosive response data:

Erythema was present at each observation time through Day 17. Edema was present at each observation time through Day 7. The maximum irritation score of 4.2 our of a possible 8.0 was obtained at the one hour observation.

Observation Time	ERYTHEMA FORMATION						EDEMA FORMATION						OTHER OBSERVATIONS						IRRITATION SCORE
	Rabbit Number						Rabbit Number						Rabbit Number
	1M	2M	3M	4F	5F	6F	1M	2M	3M	4F	5F	6F	1M	2M	3M	4F	5F	6F
0 Hours	2	2	2	2	2	2	2	2	2	2	2	3	0	0	0	0	0	0	4.2
24 Hours	2	1	2	2	2	2	2	1	1	1	1	2	0	0	0	0	0	0	3.2
48 Hours	2	1	1	2	1	1	1	1	1	1	1	1	0	0	0	0	0	0	2.3
72 Hours	2	1	3	1	1	1	1	1	1	1	1	1	0	0	0	0	0	0	2.5
Day 7	1	1	3	1	1	1	0	0	1	0	1	1	0	0	0	0	0	0	1.8
Day 9	0	0	1	0	1	1	0	0	0	0	0	0	S	S	S	S	S	S	0.5
Day 13	0	0	1	0	1	1	0	0	0	0	0	0	S	S	S	S	S	S	0.5
Day 17	0	0	0	0	0	1	0	0	0	0	0	0	0	S	0	0	S	S	0.2
Day 20	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	S	0.0

Maximum Irritation Score = 4.2

M – Male; F – Female

S – Sloughing of skin of various thicknesses

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Reported skin irritation results for the test animals do not meet the criteria for irritant or mild irritant under GHS.

Executive summary:

The study was conducted on six New Zealand White rabbits, 3 male and 3 female, to determine the skin irritation potential of the test material. The animals were individually housed, equilibrated in the laboratory, and released from quarantine prior to testing. Normal growth, appearance, and behavior during the equilibration period were factors used to select healthy animals for testing.

Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to expose an area at least eight centimeters by eight centimeters. Care was taken to avoid abrading the skin. Only those animals with exposure areas free from pre-existing skin irritation or defects were selected for testing.

There was one intact skin test site per animal. East test site was treated with 0.5 milliliters of actual undiluted test material by introducing the test material at room temperature beneath a surgical gauze patch measuring 1 inch x 1 inch and two single layers thick. Each patch was secured in place with a strip of a non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) to retard evaporation of volatile substances and to prevent the animals from possibly ingesting any of the test material. To secure the wrappings in place, the edges of the dressing were wrapped with a non-irritating adhesive tape in a manner which would not cdause discomfort to the animals. The animals were then returned to their cages.

Four hours after treatment the wrapping, tape, and gause patches were removed. The backs of the animals were gently washed with room temperature tap water and a wet cloth to remove as much residual test material as possible. The animals were observed for erythema and eschar formation, edema formation, and any other dermal defects or irritation at 0, 24, 48, and 72 hours and on Days 7, 9, 13, 17, and 20 (Day 0 considered day of treatment) after washing. For each observation time, all of the erythema and edema scores were added, and the sum was divided by the number of animals observed to determine an irritation score.

Erythema was present at each observation time through Day 17. Edema was present at each observation time through Day 7. The maximum irritation score of 4.2 our of a possible 8.0 was obtained at the one hour observation.

Reported skin irritation results for the test animals do not meet the criteria for irritant or mild irritant under GHS.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well conducted study for read-across substance performed according to established protocol.

Qualifier:

according to guideline

Guideline:

other: Lehman, A.J. et al., in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc., Food and Drug Officials of the U.S., Second Printing, Topeka, Kansas 1965

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

100%

Duration of treatment / exposure:

One-time treatment of one eye per rabbit

Observation period (in vivo):

Test animals observed at 1, 24, 48, and 72-hour, and 7 days.

Number of animals or in vitro replicates:

Six

Details on study design:

Six New Zealand albino rabbits were used to determine the degree of ocular irritation resulting from the addition of the test material, Conoco LPA Solvent 8558-G, into the conjunctival sac of the animals.
The animals were individually housed in metal cages elevated above the droppings with feed, consisting of Purina Rabbit Chow and tap water freely available at all times.
Both eyes of each animals were examined with Fluoroscein Sodium Ophthalmic solution U.S.P. 4 hours before testing and only those animals without observable eye defects or irritation were used.
One-tenth milliliter of the test material was placed in one eye of each animals by gently pulling the lower lid away from the eyeball to form a cup into which the test material was deposited. The lids were then gently held together for one second and the animals was released. The other eye was not treated and served as a control. The eyes were not washed following instillation of the test material except as noted below. All animals were immobilized in a suitable animal restrainer for 1 hour subsequent to treatment.
The eyes were examined and the grade of ocular reaction was recorded at 1, 24, 48 and 72 hours and at 7 days, using the scale for scoring ocular lesions as outlined by Lehman, A.J. et al., in Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics Assoc., Food and Drug Officials of the U.S., Second Printing, Topeka, Kansas 1965. The evaluation of the data was in accordance with Section 191.12 Chapter 1, Title 21, Code of Federal Regulations under the FHSA.
After the initial examination at 24 hours all eyes were washed with sufficient clean tap water at body temperature to remove the residual test sample. All eyes were further examined by placing one drop of Fluorescein Sodium Ophthalmic solution U.S.P. on the cornea. After 5 minutes the excess fluoroscein was flushed out with sufficient tap water. Injured areas of the cornea appeared greenish yellow following application of fluoroscein.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 hr

Score:

>= 0 - <= 5

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.66

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

Within one hour, barely perceptible erythema of the palpebral and bulbar conjunctivae, chemosis of the lids and an accumulation of watery discharge (3 animals only). The erythema and discharge did not last 24 hours. The chemosis was present at a barely perceptible level in three test eyes for 72 hours. All animals were normal by 7 days. A maximum average score of 5.0 was recorded at 1 hour.

RESULTS:

Rabbit No.	Structure	1 Hour	24 Hours	48 Hours	72 Hours	7 Days
1	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctivae	6	2	2	0	0
2	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctivae	4	2	0	0	0
3	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctivae	4	0	0	0	0
4	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctivae	6	2	2	2	0
5	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctivae	4	2	0	0	0
6	Cornea	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctivae	6	2	2	2	0
Average		5.0	1.7	1.0	0.7	0.0

 

 

 

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Reported results of cornea, iris, and conjunctivae scores for all six test animals do not meet the criteria for classification as an irritant.

Executive summary:

Conoco LPA Solvent 8558 -G, when instilled undiluted into the conjunctival sac of six New Zealand albino rabbits and the treated eyes not washed following instillation of the test material, produced, within 1 hour, a barely perceptible to slight erythema, chemosis and water discharge (3 of 6 animals). This showed improvement throughout the study period. By 24 hours, the erythema had disappeared and only chemosis remained (5 of 6). By 72 hours only a barely perceptible chemosis remained in 3 of 6 test eyes. At 7 days, all test eyes were normal.

Mean corneal opacity, iritis, and conjuctivae scores for the test animals averaged over 24, 48, and 72 hours were insufficient to classify; therefore, the test material is considered not irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Reported read-across data support the conclusion that the registered substance is not irritating for skin or eye when compared against GHS criteria.