Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich

Endpoint summary

Description of key information

Skin Irritation

Irritating to the skin

 

Eye Irritation

Not irritating to eyes

 

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich, is a respiratory irritant.

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

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable, well-documented publication, but it deviates from OECD Guideline 404 in that test substance was applied for 24 hours.

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Test substance was applied for 24 hrs.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-3 kg

Type of coverage:

semiocclusive

Preparation of test site:

other: both intact and abraded shaved skin was tested

Duration of treatment / exposure:

24 hrs

Observation period:

24 and 72 hrs

Number of animals:

6 males

Details on study design:

TEST SITE
- Type of wrap if used: gauze

SCORING SYSTEM: Draize

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hrs

Score:

1.92

Max. score:

3

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: 24/48/72h's score not specified

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: 24/48/72h's score not specified

Irritant / corrosive response data:

All six rabbits showed irritation ranging from a score of 1 to 3 on both intact and abraded skin.

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The primary dermal irritation index (PDII) was 1.92 which is calculated from the average erythema score and the average oedema score. Additionally, the exposure period was 24 hours.

Executive summary:

This study examined the potential of the test substance hexane to cause irritation to skin. Test substance was applied to both intact and abraded skin of 6 male rabbits. The test area was covered with gauze for 24 hrs. After the exposure period, the animals were scored for irritation at 24 and 72 hrs after start of exposure. The primary dermal irritation index (PDII) was 1.92 which is calculated from the average erythema score and the average oedema score. Additionally, the exposure period was 24 hours.

Reference 2

Endpoint:

skin irritation: 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

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable, well-documented study report that follows a protocol similar to OECD Guideline 405.

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-3 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral eye used as control

Amount / concentration applied:

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

Duration of treatment / exposure:

72 hrs

Observation period (in vivo):

72 hrs

Number of animals or in vitro replicates:

6 males

Details on study design:

SCORING SYSTEM: Draize

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hrs

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

1 animal had a redness score of 1 at 24 hrs. No other signs of irritation were noted.

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The mean conjunctivae, chemosis, iris, and cornea scores were 0.33, 0.0, 0.0 and 0.0 respectively.

Executive summary:

This study examined the potential of hexane to cause irritation to eyes. Approximately 0.1 ml of test substance was placed in the eyes of six male rabbits. The rabbits were examined for signs of irritation at 24, 48, and 72 hrs after start of exposure. Only 1 animal showed signs of irritation (score of 1) at 24 hrs. The mean conjunctivae, chemosis, iris, and cornea scores were 0.33, 0.0, 0.0, and 0.0 respectively. 

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, C5-C7, n-alkanes, isoalkanes, n-hexane rich. However, data is available for structural analogue, C6 aliphatics, <5% n-hexane and 5-80% n-hexane and presented in the dossier. This data is read across toHydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich 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

 

5 -80% n-hexane

A study (Hine, 1970) examined the potential of the test substance hexane to cause irritation to skin. Test substance was applied to both intact and abraded skin of 6 male rabbits. The test area was covered with gauze for 24 hrs. After the exposure period, the animals were scored for irritation at 24 and 72 hrs after start of exposure. The primary dermal irritation index (PDII) was 1.92 which is calculated from the average erythema score and the average oedema score. Additionally, the exposure period was 24 hours.

C6 aliphatics, <5% n-hexane

A supporting study (Shell, 1987) examined the skin irritancy of the test substance SBP 60/95 LNH. Groups of six rabbits had 0.5 ml of test substance applied to their dorsal skin. The test area was covered semi-occlusively, and exposure lasted 4 hrs. The test area was then washed. Animals were scored at 30 min., 24 hrs, 48 hrs, 72 hrs, and 7 days after removal of the test substance. The average erythema score (24,48, and 72 hours) was 0.8. The average edema score (24,48, and 72 hours) was 0.0. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.  

Eye Irritation

 

5 -80% n-hexane

In a key study (Hine, 1970) the potential of hexane to cause irritation to eyes was examined. Approximately 0.1 ml of test substance was placed in the eyes of six male rabbits. The rabbits were examined for signs of irritation at 24, 48, and 72 hrs after start of exposure. Only 1 animal showed signs of irritation (score of 1) at 24 hrs. The mean conjunctivae, chemosis, iris, and cornea scores were 0.33, 0.0, 0.0, and 0.0 respectively. 

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich, is a respiratory irritant.

Justification for classification or non-classification

Skin Irritation:

Based on available read across data, skin irritating effects are expected from the exposure to Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich. Therefore the substance is considered as a skin irritant and classified as a Category 2 skin irritant under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).

Eye Irritation:

Based on available read across data, Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich does not meet the criteria for classification as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).

Respiratory Irritation:

There are no studies that warrant classification as a respiratory irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP)