Hydrocarbons, C7-C8, isoalkanes, <2% aromatics

Endpoint summary

Description of key information

There is no data available for Hydrocarbons, C7-C8, isoalkanes, <2% aromatics. However, data is available for structural analogue, Hydrocarbons, C7-C9, isoalkanes, <2% aromatics and presented in the dossier. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Skin irritation: Irritating to the skin

Eye irritation: Not irritating to eyes

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of 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: GLP guideline study

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Cunicole de Val de Selle, Prouzel, France
- Weight at study initiation: average weight: 2.4 ± 0.05 kg
- Housing: individually housed; polystyrene cages with feeding bottles and troughs
- Diet: Lapins entretien référence 112 C (U.A.R., Villemoisson-sur-Orge, France); ad libitum during the study
- Water: filtered drinking water; ad libitum during the study
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin areas of the test animals served as controls

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

15 days after application (at 1, 24, 48, 72 hours and thereafter daily)

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 6 square centimetre
- Type of wrap if used: gauze bandage and compress


SCORING SYSTEM: OECD Draize Scoring System

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

other: reversible on day 8, but dryness of the skin

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

other: reversible on day 9, but dryness of the skin

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Irritant / corrosive response data:

At 1 hour after exposure, erythema were observed for all three animals and edema for two of three animals.

Interpretation of results:

other: Irritating

Remarks:

Criteria used for interpretation of results: other: GHS (EU, 2007)

Conclusions:

The test substance was irritating to the skin according to the criteria of the EU and the GHS.

Executive summary:

The test substance was irritating to the skin according to the criteria of the EU and the GHS.

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

18 September 2000 - 26 July 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products Inc. (formerly HRP), Denver, PA, USA
- Age at study initiation: approximately 15 - 16 weeks
- Weight at study initiation: 2.41 - 2.73 kg
- Housing: single housed during study; suspended stainless steel and wire mesh with absorbent paper below cages
- Diet (e.g. ad libitum): PMI Certified Rabbit Diet 5322; feed was analysed and not contaminated; the animals received new feed each day and the old feed, if any, was discarded. Availability of feed was checked at least once daily for all animals.
- Water (e.g. ad libitum): ad libitum, automatic watering system; water was analysed and not contaminated; availability of water was checked at least once daily for all animals
- Acclimation period: 22 days; animals were examined for viability at least once daily
- Other: animal identification by ear tags and corresponding cage identification


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8 - 22.2°C (64 - 72 degrees Fahrenheit)
- Humidity (%): 30 - 70 % relative humidity
- Photoperiod (hrs dark / hrs light): approx. 12 h light (06.00 - 18.00) and 12 h dark (18.00 - 06.00)

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

see observation period: The test substance was not washed out.

Observation period (in vivo):

1, 24, 48, 72 hours and 7 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize Standard Eye Irritation Grading Scale (Draize 1959: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the US, vol. 49, pp. 2-56.

TOOL USED TO ASSESS SCORE: 2 % sodium fluorescein

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect

Irritant / corrosive response data:

Ocular instillation of the test substance elicited conjunctival responses in all animals. Iridic and corneal responses were not evident during the study. Conjunctival responses consisted of redness of Grade 2 in all animals and discharge of Grade 1 and Grade 2 for one animal each at the 1 hour evaluation. Discharge was not evident after the 1 hour evaluation but redness of Grade 1 was noted for 2 animals at the 24 and 48 hour evaluations. Redness of Grade 1 also was noted for all animals at 72 hour evaluation. Irritation was not evident at the Day 7 evaluation and the study was terminated.

Other effects:

All animals survived the study termination and were free of clincial signs during the study.

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: other: GHS (EU, 2007)

Conclusions:

Based on the study design the test substance, hydrocarbons, C7-C9, isoalkanes, is not irritating.

Executive summary:

Based on the study design the test substance, Hydrocarbons, C7-C9, isoalkanes, is not irritating.

Reference 2

Endpoint:

eye 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: Basic data given

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Principles of method if other than guideline:

according to the Federal Register of the F.D.A. 28 (110), 6.6.1963, para. 191.12. Test for eye irritants

GLP compliance:

no

Remarks:

Not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain: albino
- Source: Ranch Rabbits, Crawley, Sussex
- Weight at study initiation: 3 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

0.2 mL

Duration of treatment / exposure:

single application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

2 males, 2 females

Details on study design:

Undiluted solvent was instilled into the conjunctival sac of the right eye of two male and two female albino rabbits; the untreated left eye served as a control. A visual assessment of irritancy was made half an hour after application and again 1, 2, 3 and 7 days later.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 0.5 hrs - 7 days

Score:

0

Max. score:

4

Reversibility:

not specified

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Conjunctiva redness, chemosis and discharge, Cornea opacity and area, and Iris were scored in 4 animals. In all 4 animals only at timepoint 0.5 hr a very mild irritancy was observed in conjunctiva redness and scored 0 - 1. Thus the overall score can be considered to be 0.

Table: Individual Eye Irritation Scores

Animal		1/2 hr	24 hrs	48 hrs	72 hrs	7 days
1351 Female	Cornea, opacity	0	0	0	0	0
	Cornea, area	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctiva, redness	0-1	0	0	0	0
	Conjunctiva, chemosis	0	0	0	0	0
	Conjunctiva, discharge	0	0	0	0	0
1352 Male	Cornea, opacity	0	0	0	0	0
	Cornea, area	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctiva, redness	0-1	0	0	0	0
	Conjunctiva, chemosis	0	0	0	0	0
	Conjunctiva, discharge	0	0	0	0	0
1422 Female	Cornea, opacity	0	0	0	0	0
	Cornea, area	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctiva, redness	0-1	0	0	0	0
	Conjunctiva, chemosis	0	0	0	0	0
	Conjunctiva, discharge	0	0	0	0	0
1423 Male	Cornea, opacity	0	0	0	0	0
	Cornea, area	0	0	0	0	0
	Iris	0	0	0	0	0
	Conjunctiva, redness	0-1	0	0	0	0
	Conjunctiva, chemosis	0	0	0	0	0
	Conjunctiva, discharge	0	0	0	0	0

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: other: EU, GHS, 2007

Conclusions:

The purpose of this test was to determine the irritation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rabbit eye. 0.2 mL of test substance was added to the right eye of two male and two female rabbits. The animals were scored for irritation at 0.5 hrs after applications, and also at 1, 2, 3, and 7 days after application. All animals showed conjunctival redness (score of 0-1) at the 0.5 hr observation. No other signs of irritation were noted. The test substance is not irritating to eyes according to OECD GHS guidelines.

Executive summary:

The purpose of this test was to determine the irritation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rabbit eye. 0.2 mL of test substance was added to the right eye of two male and two female rabbits. The animals were scored for irritation at 0.5 hrs after applications, and also at 1, 2, 3, and 7 days after application.

All animals showed conjunctival redness (score of 0-1) at the 0.5 hr observation. No other signs of irritation were noted. The test substance is not irritating to eyes according to OECD GHS guidelines.

Reference 3

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There is no data available for Hydrocarbons, C7-C8, isoalkanes, <2% aromatics. However, data is available for structural analogues, Hydrocarbons, C7-C9, isoalkanes, <2% aromaticsandHydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics, and presented in the dossier. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

 

Skin Irritation

Hydrocarbons C7-C9, isoalkanes, <2% aromatics

The skin irritation potential of Hydrocarbons C7-C9, isoalkanes, <2% aromatics was determined according to OECD 404 (Total Solvants, 2000a). The test substance was applied to the intact skin of rabbits for 4 hours under semi occlusive conditions. After removal of the test substance, no edema, but well-defined to moderate erythema were noted in all three animals. Irritating effects were reversible within 9 days. Under the test conditions, the test substance was irritating to the skin.

 

Eye Irritation

Hydrocarbons C7-C9, isoalkanes, <2% aromatics

The eye irritation potential of the hydrocarbons, C7-C9, isoalkanes was determined by instillation of 0.1 mL of the test material into the conjunctival sac of 3 rabbits (ExxonMobil, 2004a). Ocular reactions were examined and scored 1, 24, 48, 72 hours after application. At the 1 hour evaluation, conjunctival redness (grade 2) was observed in all animals. Conjunctival redness (grade 0-1) was also noted in all animals at the 72 hour evaluation. All redness was reversible within 7 days. No corneal opacity, iritis or conjunctival chemosis was noted in any of the 3 rabbits.

 

Two further studies, performed according to OECD 404, showed that no ocular irritation in any animal at any time point could be observed for the compounds ISOPAR E and ISOPAR C (both studies from ExxonMobil, 1997a,b). In another study of ExxonMobil (1962c) conducted similar to OECD 405, at 1 hour after administration, 4 of 6 animals showed slight erythema which completely subsided by the 4 hour observation. The remaining 2 animals showed slight or moderate erythema, slight edema, and slight discharge. These irritating effects were fully reversible within 72 hours after administration. Under the test conditions, the test substance was not irritating to the eyes.

Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics

 

A key test (Shell, 1977) was conducted to determine the irritation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics to rabbit eye. 0.2 mL of test substance was added to the right eye of two male and two female rabbits. The animals were scored for irritation at 0.5 hrs after applications, and also at 1, 2, 3, and 7 days after application. All animals showed conjunctival redness (score of 0-1) at the 0.5 hr observation. No other signs of irritation were noted. The test substance is not irritating to eyes according to OECD GHS guidelines.

Justification for classification or non-classification

Based on the available read across data, Hydrocarbons, C7-C8, isoalkanes, <2% aromatics warrants classification as a skin irritant (Skin Irritation Category 2) under the Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).

 

Based on the available read across data, Hydrocarbons, C7-C8, isoalkanes, <2% aromatics does not warrant classification as an ocular or respiratory irritant under the Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).