Petroleum kerosene fraction, co-processed with renewable hydrocarbons of plant and/or animal origin

Endpoint summary

Description of key information

Animal studies with kerosine indicate the material is irritating to rabbit skin (method similar to OECD 404).

Kerosine was found to be non-irritating to rabbit eyes when exposed to 0.1 mL of test substance (OECD 405).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable and well-documented study report.

Justification for type of information:

Read across justification included in Section 13

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: EPA Guidelines in FR Vol. 44, No. 145, pgs. 44054-44093

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Alpine Rabbitry, Sandy, Utah
- Age at study initiation: 8-14 weeks old
- Weight at study initiation: 1.8-2.3 kg
- Housing: caged individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 66-74 degrees F
- Humidity (%): 29-53%
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

other: intact skin

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

24 hour(s)

Observation period:

24 and 72 hours and 4,5,6,7,8,9,10 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 1" square
- Type of wrap if used: covered with 1" square gauze pads stabilized with a strip of hypoallergenic tape after which a dental dam was applied to the test sites and secured with 3" wide tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize (1959).

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

24 h

Score:

3.13

Max. score:

4

Reversibility:

not fully reversible within: 10 days

Remarks on result:

other: erythema scores ranging from 2-4 in all except one animal who scored 1 at 24 hours

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

mean

Time point:

72 h

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within: 10 days

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

24 h

Score:

2.42

Max. score:

4

Reversibility:

not fully reversible within: 10 days

Remarks on result:

other: scores ranged mostly from 2-4

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

mean

Time point:

72 h

Score:

1.92

Max. score:

4

Reversibility:

not fully reversible within: 10 days

Observation for irritation was extended to 10 days. Although the degree of edema declined throughout the observation period, the degree of erythema and eschar did not decline so markedly. Scores for the range of erythema and edema as well as the average irritation scores and their ranges are summarised in the following table.

Obs. period	Range of scores		Irritation index
	Erythema	Edema	Mean	Range
24 hr	1-4	0-4	5.6	1.0-7.5
72 hr	2-4	1-3	5.4	3.8-6.2
4 day	3-4	1-3	5.4	4.5-6.0
5 day	2-4	0-2	4.9	4.0-6.0
6 day	1-4	0-1	4.3	3.5-4.8
7 day	1-4	0-1	4.0	3.2-4.8
8 day	1-3	0-2	3.3	2.0-4.2
9 day	1-3	0-1	3.2	2.2-4.0
10 day	0-4	0-1	3.7	2.2-4.0

On the basis of these findings, the test material was described as a moderate dermal irritant.

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The mean erythema and edema scores over 72 hours (i.e., average of 24 and 72 hour readings) were 3.46 and 2.33 for intact skin for each endpoint respectively. The test material was classified as irritating according to EU criteria.

Executive summary:

In a primary dermal irritation study, 6 female New Zealand White rabbits were dermally exposed to undiluted Kerosine/heating oil (0.5mL per test site). Two of the test sites on each rabbit were intact skin. After exposure, the test site was covered with a gauze pad and the trunk of the rabbit was wrapped in an impervious covering. Twenty-four hours later the patches were removed and any residual material was wiped from the skin. Each of the test sites was evaluated for skin responses within 60 minutes of patch removal (24 hour reading), and again at 72 hours, then daily until 9 days post-application. The responses were scored using the Draize scale.

The mean erythema and edema scores over 72 hours (i.e., average of 24 and 72 hour readings) were 3.46 and 2.33 for intact skin for each endpoint respectively. The test material was classified as irritating according to EU criteria.  

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable and well-documented study report.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1990-08-28 to 1992-04-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was carried out according to EPA OTS 798.4500.

Justification for type of information:

Read across justification included in Section 13

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: J. Leslie Furs, American Fork, Utah
- Age at study initiation: young adult
- Weight at study initiation: 2.0 to 4.0 kilograms
- Housing: housed separately in stainless steel, wire meshed bottomed cages
- Diet: fresh certified Agway rabbit feed was provided ad libitum
- Water: fresh potable water was provided ad libitum
- Acclimation period: seven days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 21 degrees celsius, within protocol limits
- Humidity (%): 40 to 60%, within protocol limits
- Air changes: no less than ten air changes per hour
- Photoperiod: 12 hours light/ 12 hours dark


IN-LIFE DATES:

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye on each animal served as untreated control

Amount / concentration applied:

0.1 mL of undiluted liquid test article

Duration of treatment / exposure:

single treatment, eyelids held together for approximately 1 second post dosing.

Observation period (in vivo):

observations were made at pre-screening, 1, 24, 48, and 72 hours

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no data provided on washing



SCORING SYSTEM: Eye irritation scores were generated using the Draize system. Scores were collected at the 24 and 72 hour intervals and were used to determine the Primary Eye Irritation Index.


TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

80

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

10

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

12

Remarks on result:

other: all 3 animals had conjunctivae scores of 6 at 1 hour which fully resolved by 24 hours

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

Remarks on result:

other: all 3 animals had conjunctivae scores of 2 at 1 hour which fully resolved by 24 hours

Irritant / corrosive response data:

At pre-screening all animals were free of ocular lesions. There was no evidence of damage to the cornea or iris for all animals at all scoring periods. Mild conjunctivae indicators such as redness, chemosis, and discharge were evident at the one hour scoring interval, and at no other scoring interval. Fluorescein staining scores were zero for all study animals over all scoring periods.

Other effects:

No ocular lesions were seen in the untreated control eyes during the study period.

All three rabbits had an ocular reaction 1 hour after instillation of the test material; the score for each animal was 8.0. No irritation was observed thereafter.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the mean cornea, iris, and conjunctivae scores of 0.0 calculated for all three test animals using the 24, 48, and 72 hour readings, thermocracked kerosine is considered not irritating according to EU criteria.

Executive summary:

In a primary eye irritation study, 0.1 mL/eye of undiluted thermocracked kerosine was instilled into the conjunctival sac of the right eye of three female young adult New Zealand White rabbits, and their eyelids held together for one minute after instillation. Observations were made at pre-screening, 1, 24, 48, and 72 hours. Irritation was scored according to the Draize method.

At pre-screening all animals were free of ocular lesions. There was no evidence of damage to the cornea or iris for all animals over all scoring periods. Mild conjunctivae indicators such as redness, chemosis, and discharge were evident at the one hour scoring interval, and at no other scoring interval. Fluorescein staining scores were zero for all study animals over all scoring periods. The mean cornea, iris, and conjunctivae scores (24, 48, and 72 hours) were all 0.0. Thermocracked kerosine is not irritating to the eye according to EU criteria.

This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was carried out according to EPA OTS 798.4500.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Data on related substances have been used to 'read-across' and predict the hazard properties. A 'read-across' justification document can be found in section 13.

Animal studies with the closely related hdrodesulphurised kerosine indicate that the material may act as a skin irritant, but is not irritating to the eye.

 

Skin irritation

In the key study (ARCO, 1986d), young adult rabbits (6 females) were dermally exposed (occlusive coverage) to 0.5 mL of undiluted kerosine/heating oil for 24 hours on both intact and abraded skin sites. Each of the test sites was evaluated for skin responses for 9 days post-exposure, and was scored using the Draize scale. The mean erythema score from 24 to 72 hours was 3.46/4 while the mean edema score from 24 to 72 hours was 2.33/4. While this protocol deviates from current guidelines that state exposure should be semi-occlusive over 4 hours, and to intact skin only, this study is included as key to show the irritating nature of kerosine products.

 

Eye irritation

In a key study, hydrodesulphurised kerosine was instilled into the eye of six NZW rabbits. Treatment provoked only minimal transient reaction (redness and swelling).

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the results of dermal studies with kerosine the material is classified as irritating to the skin as defined by EU CLP Regulation (EC No. 1272/2008). It is classified as Skin Irritant Category 2 (H315), irritating to the skin. 

Based on a lack of corneal, iridial, and conjunctival irritation, kerosines do not meet the criteria for classification as an eye irritant as defined by EU CLP Regulation (EC No. 1272/2008).