Alkanes, C11-12

Endpoint summary

Description of key information

Skin Irritation

Not irritating to the skin

 

Ocular Irritation

Not irritating to eyes

 

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C11-C12, n-alkanes, <2% aromatics 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:

2000/4/12-2000/6/22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD test guideline 404. GLP

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:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Source:Harlan UK Ltd
Number of Animals: Three
Age at study initiation: Approximately 13 weeks
Weight at study initiation: 2.7-3.2 kg
Housing: Individually
Diet (e.g. ad libitum): Special Diet Service STANRAB SQC (pellets); ad libitum
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 22d

ENVIRONMENTAL CONDITIONS
Temperature (°C): 18-21
Humidity (%): 53-65%
Photoperiod (hrs dark / hrs light): 12/12
Monitored at least once a day

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Amount(s) applied (volume or weight): 0.5 ml
Concentration (if solution): neat

Duration of treatment / exposure:

Test material was administered to the clipped backs as a single dose introduced under a gauze patch (secured with non-irritating tape) and held in contact with the skin by means of a semi-occlusive dressing for 4 hours. Residual test material was then removed.

Observation period:

24, 48, and 72h post application and once per day until Day 14

Number of animals:

Three females

Details on study design:

SCORING SYSTEM: Draize scale for dermal irritation

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

ca. 2

Max. score:

2

Reversibility:

fully reversible within: 13 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

ca. 1.7

Max. score:

2

Reversibility:

fully reversible within: 13 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

ca. 2

Max. score:

2

Reversibility:

fully reversible within: 13 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.9

Max. score:

2

Reversibility:

fully reversible within: 13 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

ca. 1.3

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.1

Max. score:

2

Reversibility:

fully reversible

Irritant / corrosive response data:

Topical application of Petrepar 134 (50/50) elicited dermal responses in all animals. Well defined erythema and slight edema followed exposure and was resolved by day 13.

Interpretation of results:

GHS criteria not met

Conclusions:

The average erythema score (24,48, and 72 hours) was 1.9, with 2 out of 3 animals having a mean (24-72 hour) erythema score of 2.0. The average edema score (24,48, and 72 hours) was 1.1. Based on the individual animal dermal irritation scores, classification as a dermal irritant is not warranted under Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Executive summary:

In this study, 3 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of Petrepar 134 (50/50) via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and once a day for a total of 14 days according to the Draize method of scoring. Topical application of Petrepar 134 (50/50) elicited dermal responses in all animals. Well defined erythema and slight oedema followed exposure and was resolved by day 13. The average erythema score (24,48, and 72 hours) was 1.9, with 2 out of 3 animals having a mean (24-72 hour) erythema score of 2.0. The average edema score (24,48, and 72 hours) was 1.1. Based on the individual animal dermal irritation scores, the test substance warrants classification as a dermal irritant is not warranted under Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

1997/04/27- 1997/07/23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report equivalent or similar to OECD guideline 404: GLP.

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:

six animals

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd
- Age at study initiation: adult
- Housing: individually
- Diet (e.g. ad libitum): Special Diets Services
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19
- Humidity (%): 50-53
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

Dermal responses were evaluated approximately 60 minutes, 24, 48, and 72 hours following patch removal.

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: dorsal surface from the shoulder region to the lumbar region
- % coverage: N/A
- Type of wrap if used: under a gauze patch secured with tape, the patch was loosely held in contact with the skin by means of a semi-occlusive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): removed residual test material using reverse osmosis water and paper towels.
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.55

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: based on scores of three animals

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.66

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter	Basis	Time Point	Score	Reversibility
erythema score	animal #1	24 hours	1	Fully reversible by 72 hours
erythema score	animal #2	24 hours	1	Fully reversible by 72 hours
erythema score	animal #3	24 hours	1	Fully reversible by 72 hours
erythema score	animal #1	48 hours	1	Fully reversible by 72 hours
erythema score	animal #2	48 hours	1	Fully reversible by 72 hours
erythema score	animal #3	48 hours	0	Fully reversible by 72 hours
erythema score	animal #1	72 hours	0	Fully reversible by 72 hours
erythema score	animal #2	72 hours	0	Fully reversible by 72 hours
erythema score	animal #3	72 hours	0	Fully reversible by 72 hours
erythema score	mean	24 hour mean	1	Fully reversible by 72 hours
erythema score	mean	48 hour mean	0.66	Fully reversible by 72 hours
erythema score	mean	72 hour mean	0	Fully reversible by 72 hours
erythema score	mean	24-72 hour mean	0.55	Fully reversible by 72 hours
edema score	animal #1	24 hours	2	Fully reversible by 72 hours
edema score	animal #2	24 hours	1	Fully reversible by 72 hours
edema score	animal #3	24 hours	1	Fully reversible by 72 hours
edema score	animal #1	48 hours	1	Fully reversible by 72 hours
edema score	animal #2	48 hours	1	Fully reversible by 72 hours
edema score	animal #3	48 hours	0	Fully reversible by 72 hours
edema score	animal #1	72 hours	0	Fully reversible by 72 hours
edema score	animal #2	72 hours	0	Fully reversible by 72 hours
edema score	animal #3	72 hours	0	Fully reversible by 72 hours
edema score	mean	24 hour mean	1.3	Fully reversible by 72 hours
edema score	mean	48 hour mean	0.66	Fully reversible by 72 hours
edema score	mean	72 hour mean	0	Fully reversible by 72 hours
edema score	mean	24-72 hour mean	0.66	Fully reversible by 72 hours

Interpretation of results:

GHS criteria not met

Conclusions:

The mean erythema and edema scores for the test material were 0.55 and 0.66 respectively. Classification as a dermal irritant is not warranted under Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Executive summary:

The test material was administered  via semi-occlusive patch for four hours to three rabbits (3 female) to assess dermal irritation  Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing according to the Draize method of scoring.  Application of the test material elicited responses in all animals.  Erythema scores decreased as the study progressed.  Effects continued to subside until all animals were free of adverse clinical signs by study termination (Day 7).   Classification as a dermal irritant is not warranted under Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Reference 3

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:

no adverse effect observed (not 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:

2000/03/08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

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 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd
- Age at study initiation: 13 weeks
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: individual
- Diet (e.g. ad libitum): Special Diet Services STANRAB SQC pellet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 25 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 -23
- Humidity (%): 36-45
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral eye

Amount / concentration applied:

0.1mL

Duration of treatment / exposure:

The eyelids were gently held together for one second before releasing.

Observation period (in vivo):

1, 24, 48, and 72 hours post-treatment

Number of animals or in vitro replicates:

3

Details on study design:

Test material was applied to the eyes and the eyelids were gently held together for one second before releasing. Irritation and toxicity were monitored at 1, 24, 48, and 72 hours post-treatment. Irritation was scored according to the Draize methodology.

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No corneal damage or iridial inflammation was observed. Hyperaemia of blood vessels of the conjuctivae was seen in all animals. Ocular reactions had resolved in all instances by one day after instillation.

Irritation parameter	Basis	Time Point	Score
conjuctivae score	animal #1	24 hours	0
conjuctivae score	animal #2	24 hours	0
conjuctivae score	animal #3	24 hours	0
conjuctivae score	animal #1	48 hours	0
conjuctivae score	animal #2	48 hours	0
conjuctivae score	animal #3	48 hours	0
conjuctivae score	animal #1	72 hours	0
conjuctivae score	animal #2	72 hours	0
conjuctivae score	animal #3	72 hours	0
conjuctivae score	mean	24 hour mean	0
conjuctivae score	mean	48 hour mean	0
conjuctivae score	mean	72 hour mean	0
conjuctivae score	mean	24-72 hour mean	0
chemosis score	animal #1	24 hours	0
chemosis score	animal #2	24 hours	0
chemosis score	animal #3	24 hours	0
chemosis score	animal #1	48 hours	0
chemosis score	animal #2	48 hours	0
chemosis score	animal #3	48 hours	0
chemosis score	animal #1	72 hours	0
chemosis score	animal #2	72 hours	0
chemosis score	animal #3	72 hours	0
chemosis score	mean	24 hour mean	0
chemosis score	mean	48 hour mean	0
chemosis score	mean	72 hour mean	0
chemosis score	mean	24-72 hour mean	0
cornea score	mean	24-72 hour mean	0
iris score	mean	24-72 hour mean	0

Interpretation of results:

GHS criteria not met

Conclusions:

The mean conjunctivae, chemosis, iris, and cornea scores for the Petrepar 134 (60/40) were 0.0, 0.0, 0.0, and 0.0 respectively. Classification as an ocular irritant is not warranted under Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Executive summary:

Petrepar 134 (60/40) (0.1 mL, neat) was administered to the right eye of three rabbits to assess occular irritation. Irritation and toxicity were monitored at 1, 24, 48, and 72 hours post-treatment. Irritation was scored according to the Draize methodology. No corneal damage or iridial inflammation was observed. Hyperaemia of blood vessels of the conjuctivae was seen in all animals. Ocular reactions had resolved in all instances by one day after instillation. The mean conjunctivae, chemosis, iris, and cornea scores for the Petrepar 134 (60/40) were 0.0, 0.0, 0.0, and 0.0 respectively. Classification as an ocular irritant is not warranted under Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Reference 2

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 skin or eye irritation data available for Hydrocarbons, C11-C12, n-alkanes, <2% aromatics. However, data is available for structural analogue Hydrocarbons, C11-C14, n-alkanes, <2% aromatics and presented in the dossier. Additionally, an eye irritation study in humans is available from structural analogue, Decane. This data is read across to Hydrocarbons, C11-C12, n-alkanes, <2% aromatics 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, C11-C14, n-alkanes, <2% aromatics

In a key study (Cepsa Quimica, 2000), 3 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of test material (Hydrocarbons, C11-C14, n-alkanes, <2% aromatics) (50/50) via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and once a day for a total of 14 days according to the Draize method of scoring. Topical application of test material (50/50) elicited dermal responses in all animals. Well defined erythema and slight oedema followed exposure and was resolved by day 13. The average erythema score (24,48, and 72 hours) was 1.9, with 2 out of 3 animals having a mean (24-72 hour) erythema score of 2.0. The average edema score (24,48, and 72 hours) was 1.1. 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).

In a key study (Petrochem Carless Limited, 1997), the test material (Hydrocarbons, C11-C14, n-alkanes) was administered via semi-occlusive patch for four hours to three rabbits (3 female) to assess dermal irritation. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing according to the Draize method of scoring.  Application of the test material elicited responses in all animals. Erythema scores decreased as the study progressed.  Effects continued to subside until all animals were free of adverse clinical signs by study termination (Day 7).  Classification as a dermal irritant is not warranted under Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Ocular Irritation

 

Hydrocarbons, C11-C14, n-alkanes, <2% aromatics

In a key study (Cepsa Quimica, 2000), the test material (Hydrocarbons, C11-C14, n-alkanes, <2% aromatics) (60/40) (0.1 mL, neat) was administered to the right eye of three rabbits to assess ocular irritation. Irritation and toxicity were monitored at 1-, 24-, 48-, and 72-hours post-treatment. Irritation was scored according to the Draize methodology. No corneal damage or iridial inflammation was observed. Hyperaemia of blood vessels of the conjuctivae was seen in all animals. Ocular reactions had resolved in all instances by one day after instillation. The mean conjunctivae, chemosis, iris, and cornea scores for the test material (60/40) were 0.0, 0.0, 0.0, and 0.0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Decane

In a supporting dose-response study (Kjaergaard et al., 1989) of human reactions to the indoor air pollutant n-decane was performed in a climate chamber. Sixty-three healthy subjects, randomly selected from the normal population, were exposed to n-decane concentrations of either 0, 10, 35, or 100 uL/L in a controlled, double blind study using a Latin square exposure design. The most significant findings were dose-dependent changes in irritation of mucous membranes, increased sensation of odor intensity, and reduced air quality. Adaptation was seen at the highest exposure levels, but not at the levels relevant for a non-industrial environment. The physiological measurements showed decreased tear film stability at all exposure concentrations. The number of conjunctival polymorphonuelear leucocytes increased in a dose-related manner. Predictors of the sensitivity to exposure, i.e. mucous membrane irritation threshold and skin irritation (Stingers test), were correlated to subjective ratings of odor intensity and irritation of mucous membranes. 

 

Respiratory Irritation

 

No studies were located to indicate that Hydrocarbons, C11-C12, n-alkanes, <2% aromatics is a respiratory irritant.

Justification for classification or non-classification

Skin Irritation:

Based on available read across data, Hydrocarbons, C11-C12, n-alkanes, <2% aromatics does not meet the criteria for classification for skin irritation under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Ocular Irritation:

Based on available read across data, Hydrocarbons, C11-C12, n-alkanes, <2% aromatics does not meet the criteria for classification as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling 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).