Naphtha (petroleum), light straight-run, co-processed with hydrocarbons derived from thermally cracked waste plastics

Endpoint summary

Description of key information

Skin irritation – Irritating in rabbit skin in non-guideline study.

Eye irritation – Not irritating in rabbit (OECD TG 405).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

migrated 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: Acceptable, well-documented study report which meets basic scientific principles. GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24 hour exposure, occlusive wrap

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

other: non-abraded and abraded

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

24 hours

Observation period:

Observations were made and 24 and 72 hours and at 7 and 14 days after treatment.

Number of animals:

6 animals

Details on study design:

Observations were not made at 48 hours. Therefore, the mean erythema and mean edema scores do not reflect a 24, 48, and 72 hour average, rather they reflect a 24 and 72 hour average.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 animals

Time point:

other: 72 hrs

Score:

ca. 0.92

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Not Specified

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animals

Time point:

other: 24 hrs

Score:

ca. 0.5

Max. score:

1

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animals

Time point:

other: 72 hrs

Score:

ca. 0.5

Max. score:

1

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animals

Time point:

other: 7 days

Score:

ca. 0.92

Max. score:

1

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap

Irritation parameter:

edema score

Basis:

mean

Remarks:

24/72 hr time point average

Time point:

other: 24/72 hr

Score:

ca. 0.5

Max. score:

0.5

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Out of compliance with OECD guidelines: 24 hour exposure, occlusive wrap

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Not Specified

Other effects:

Unleaded motor gasoline was administered via an occlusive dermal patch on abraded skin. The erythema scores at 24 and 72 hours and at 7 and 14 days were 0.0, 1.0, 0.17, and 0.0, respectively. Erythema was fully reversible within 14 days after treatment. The edema scores at 24 and 72 hours and at 7 and 14 days were 0.5, 0.5, 1.08, and 0.0, respectively. Edema was fully reversible within 14 days after treatment.

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The results of this study cannot be directly interpreted for classification of skin irritation due to deviations from the EEC regulatory protocol, consisting of the use of a 24 hr, rather than a 4 hr, exposure period and the use of an occlusive, rather than a semi-occlusive, wrap.

Executive summary:

Unleaded motor gasoline (API PS-6) was administered via occlusive dermal patch on non-abraded and abraded skin of 6 New Zealand White rabbits at doses of 0.5 ml for 24 hours to assess dermal irritation. Clinical observations were made at 24 and 72 hours and at 7 and 14 days after treatment. Unleaded motor gasoline produced dermal irritation (erythema and edema) to the skin of rabbits as a result of 24 -hour exposure. Erythema was fully reversible within 7 days and edema was fully reversible within 14 days.

The erythema and edema scores of unleaded motor gasoline (API PS-6) indicated a potential to cause dermal irritation.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable,well-documented study report similar or equivalent to OECD 405. GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Amount applied: 0.1 ml

Duration of treatment / exposure:

The eyes of 6 animals were left unrinsed after administration. The eye of the 3 animals was rinsed for one minute 20 to 30 seconds after test material instillation.

Observation period (in vivo):

Observations were made at 24, 48 and 72 hours after treatment.

Number of animals or in vitro replicates:

unrinsed: 6 animals
rinsed: 3 animals

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: unrinsed; max possible score of 110

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: unrinsed; max possible score of 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: unrinsed; max possible score of 4

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: unrinsed; max possible score of 4

Irritation parameter:

iris score

Remarks:

lesion

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: unrinsed; max possible score of 2

Other effects:

Unleaded motor gasoline (API PS-6) was also instilled into the eyes of 3 rabbits, which were rinsed 20-30 seconds after dosing. This method is not in compliance with OECD TG 405 and is not appropriate for classification purposes. The overall irritation score was approximately 0.0 (max score out of 110 possible). The mean (24, 48, and 72 hr average) conjunctivae redness, chemosis, corneal opacity, and iris lesion scores were 0.0, 0.0, 0, and 0, respectively.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores were 0, 0, 0.0, and 0.0, respectively. These findings do not warrant classification of unleaded motor gasoline (API PS-6) as an ocular irritant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).

Executive summary:

Unleaded motor gasoline (API PS-6) was administered to one eye of six male New Zealand White rabbits to assess for ocular irritation. Observations were made at 24, 48 and 72 hours after treatment. Ocular damage was assessed and scored according to the Draize eye test.Ocular irritation was not observed after treatment and the overall irritation score was 0.0. The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores were 0, 0, 0.0, and 0.0, respectively. These findings do not warrant classification of unleaded motor gasoline (API PS-6) as an ocular irritant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The human literature indicates that gasoline can cause dermal irritation but does not appear to be severe dermal irritants or corrosive agents. There is some evidence of eye irritation associated with vapor exposure at levels equal to and greater than 200 ppm, but the effects were mild, and the dose-response information was not conclusive.

Similarly, gasoline produced some dermal irritation but not corrosion when applied to rabbit skin. The level of irritation was enhanced when the test materials were applied under occluded patch.. There was very little evidence of irritation when gasoline was instilled into rabbit eyes.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

The animal studies were conducted under regulatory guidelines and in accordance with good laboratory practice recommendations. The data can be used without restriction for regulatory purposes and support classification of gasoline and naphtha blending stocks as Skin Irritant 2 according to EU CLP Regulation (EC No. 1272/2008).

Gasoline and naphtha blending stocks do not meet the criteria for classification as an eye irritant according to the EU CLP Regulation (EC No. 1272/2008).

There is no need to conduct additional animal testing for these endpoints.