Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30 %)

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, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) 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:

1985/07/11 - 1985/07/31

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Justification for type of information:

The justification for read across is provided 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:

occlusive dressing used; 24 hour exposure

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles Rivers UK Ltd
-Sex: Male (10); Female (10)
- Age at study initiation: 6 weeks
- Weight at study initiation: Male: 125-135g; Female: 110-115g
- Housing: individually housed
- Diet (e.g. ad libitum): No. 1, expanded pelleted maintenance diet for rats and mice from Special Diet Services Ltd., ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6-day acclimatisation


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 58-90
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

Amount(s) applied (volume or weight): 2.0 ml
Concentration (if solution): neat

Duration of treatment / exposure:

On the day prior to application the trunk of each animal was clipped free of hair. For each treated animal, 2 mL/kg of BP83HF was applied to a patch of absorbent paper. The patch was applied to the trunk and held in place beneath a sleeve under a Poroplast bandage. The whole patch assembly was held in place with tape. The patches were left in position for approximately 24 hours. Patches were similarly applied to control animals with the omission of test material. To prevent the animals from gaining access to the sites of application (and hence possibly ingesting traces of test material), collars were applied around the animals heads for a further 24 hours (control and test animals).

Observation period:

Once per day for 14 days

Number of animals:

Control: (5) males; (5) female
2 ml/kg (converted 1.7 g/kg): (5) males; (5) females

Details on study design:

SCORING SYSTEM: Draize scale
- Dermal response observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Remarks:

after 72 hours

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

ca. 2

Max. score:

2

Reversibility:

fully reversible

Remarks:

after 72 hours

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

ca. 0.2

Max. score:

2

Reversibility:

fully reversible

Remarks:

after 72 hours

Remarks on result:

other: Only one female rabbit displayed an erythema score of 2.0 at the 72 hour observation. Reversed in all other 9 animals.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1.35

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritant / corrosive response data:

There were no animal deaths prior to study termination. Well-defined erythema was noted upon removal of the test patches in all animals exposed to BP83HF, generally persisting for a further 24 hours. Scab formation was subsequently observed on Day 5 and skin flaking was noted on Day 6 in all treated animals, persisting for a few days only in most animals. Plaster marks were noted on all test and control animals following patch removal; this is an artifact of the test procedure and is commonly seen in studies of this type. No other significant signs of ill health, behavioral change or reaction to treatment were noted.

Other effects:

The body weight gain of male rats was unaffected by treatment with the test material. A marginally larger overall weight gain was recorded for treated female rats when compared with the controls; this was considered to have arisen fortuitously and not related to treatment with BP83HF.

Post mortem examination of all animals killed at termination revealed an area of diffuse subcutaneous haemorrhage beneath the dorsal patch site in one male exposed to BP83HF. However, no other findings considered to be related to treatment were observed and no tissues were processed further for histopathological examination.

Post mortem examination of all animals killed at termination revealed an area of diffuse subcutaneous haemorrhage beneath the dorsal patch site in one male exposed to BP83HF. However, no other findings considered to be related to treatment were observed and no tissues were processed further for histopathological examination.

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The average erythema score (24, 48, and 72 hours) was 1.35.   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.

Executive summary:

In this study, 10 rabbits were exposed to 2.0 ml of BP83HF via an occlusive patch. Dermal responses were evaluated once a day for 14 days.  Skin irritation was scored according to the Draize method of scoring. At the 24 and 48 hour observations, all animals were noted with a well defined erythema.  Only one animal was noted with well defined erythema at the 72 hour observation.  After 72 hours, all animals were free of dermal irritation.  The average erythema score (24, 48, and 72 hours) was 1.35.   This study was conducted to acceptable, well-documented scientific principles.  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.

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:

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:

1985/07/22-1985/07/25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented study report which meets basic scientific principles: GLP

Justification for type of information:

The justification for read across is provided 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)

Deviations:

yes

Remarks:

no 72 hour observation, but material demonstrated no irritation at 24 and 48 hours

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ranch Rabbits
- Sex: 3 females
- Weight at study initiation: 2.4 to 3.0 kg
- Housing: Individually
- Diet (e.g. ad libitum): Guinea Pig Maintenance Diet, from Special Diet Services, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 46-71
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated contra-lateral eye

Amount / concentration applied:

Amount(s) applied (volume or weight): 0.1 ml
Concentration (if solution): neat

Duration of treatment / exposure:

Test material was introduced into one eye of each animal. The eyelids were held together for approximately one second, and then released to allow observation of the reaction of the animal.

Observation period (in vivo):

1, 24, and 48h post instillation and once per day on days 4 and 7. For each observation, reference was made to the contra-lateral (untreated) eye.

Number of animals or in vitro replicates:

3 female rabbits

Details on study design:

SCORING SYSTEM: Draize scale for ocular irritation.

The presence of damage to the tissues of the eye was investigated by fluorescein staining at each observation except those on the day of exposure. Any ocular reactions not adequately described by the scoring system or in structures not mentioned were recorded in full. At the completion of the observation period the rabbits were killed by cervical dislocation.

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 hour

Score:

1

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1 hour

Score:

1

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 1 hour

Score:

1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48 h

Score:

0

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: no irritation was noted after the 1 hour observation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48 h

Score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: Mean score at 24-48 hour observation was 0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: Mean score at 24-48 hour observation was 0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: Mean score at 24-48 hour observation was 0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: Mean score at 24-48 hour observation was 0

Irritant / corrosive response data:

All animals exhibited a conjunctival redness score of 1 at the 1 hour time point. All irritation scores were zero at the 24 and 48 hour observation time points.

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The mean (24-48 hour) corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for BP83HP were 0, 0, 0, and 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) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

This study was conducted to determine the potential of BP83HP to cause irritation to the eye in a rabbit model system. The eyes of six rabbits were instilled with 0.1 ml of BP83HP, neat. Ocular examinations occurred at 1h, 24h, and 48h post instillation. Ocular damage was assessed and scored according to the Draize method. All animals survived the exposure. There was slight irritation noted (conjunctivae score of 1) at the 1 hour observation point. There was no irritation at the 24 and 48 hour observations. The mean (24-48 hour) corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for BP83HP were 0, 0, 0, and 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) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

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 data available for Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%). However, data is available for structural analogue, Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%). 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, C11 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%)

In a key study (DHC Solvents Chemie GmbH, 1985), 10 rabbits were exposed to 2.0 ml of the test material (Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%)) via an occlusive patch. Dermal responses were evaluated once a day for 14 days.  Skin irritation was scored according to the Draize method of scoring. At the 24 and 48 hour observations, all animals were noted with a well-defined erythema.  Only one animal was noted with well-defined erythema at the 72 hour observation. After 72 hours, all animals were free of dermal irritation. The average erythema score (24, 48, and 72 hours) was 1.35. This study was conducted to acceptable, well-documented scientific principles. 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).

 

Ocular Irritation

Hydrocarbons, C11 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%)

A key study (DHC Solvents Chemie GmbH, 1985) was conducted to determine the potential of the test material (Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%)) to cause irritation to the eye in a rabbit model system. The eyes of six rabbits were instilled with 0.1 ml of the test material, neat. Ocular examinations occurred at 1h, 24h, and 48h post instillation. Ocular damage was assessed and scored according to the Draize method. All animals survived the exposure. There was slight irritation noted (conjunctivae score of 1) at the 1 hour observation point. There was no irritation at the 24 and 48 hour observations. The mean (24-48 hour) corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for the test material were 0, 0, 0, and 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).

 

Respiratory Irritation

No studies were located to indicate that Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) is a respiratory irritant.

Justification for classification or non-classification

Skin Irritation:

Based on available read across data, Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) 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, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) does not meet the criteria for classification as ocular irritants 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).