Docosane

Endpoint summary

Description of key information

No key or supporting data is available for docosane. However, key skin and eye irritation data is available from a structurally related substance, C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) and is presented below:

Dermal irritation: C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Eye irritation: A single application of C18 -C50 branched, cyclic and linear hydrocarbons - Distillates (CAS# 848301 -69 -9) to the non-irrgated eye of three rabbits produced minimal conjunctival irritation. One treated eye appeared normal at the 24 -hour observation and the remaining two treated eyes appeared normal at the 48-

hour observation. The substance does not meet the criteria to be classified as an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 31 January 2008 and 08 February 2008.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

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)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: 21/8/2007. Date of signature: 15/10/2007

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation:2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (Certified Rabbit Diet) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 17 to 23°C.
- Humidity (%): The relative humidity was set ti achieve limits of 30 to 70%.
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continous light and twelve hours darkness.

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of the test material.

Duration of treatment / exposure:

4 h

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patch, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the 4 hour exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours after application the corset and patch were removed from the animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: Four hours

SCORING SYSTEM:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the Draize scale (see below):

Other:
Measurement of pH:
The pH of the test material was determined prior to commencement of the study and found to be as follows:
90% v/v aqueous preparation of the test material - pH: approx 8.9 immediately, approx 8.6 after 10 minutes.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

: animal 67060 (female)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

: animal 67162 (male)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

: animal 67163 (male)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

: animal 67060 (female)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

: animal 67162 (male)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

: animal 67163 (male)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Other effects:

No corrosive effects were noted.

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC (Dangerous Substances Directive).
The test material did not meet the criteria for classifcation as a skin irritant according to EU CLP regulations.

Executive summary:

Introduction.

The study was performed to assess the irritancy potential of the test material ‘Distillates (Fischer-Tropsch), heavy, C18-50 - branched, cyclic and linear’ to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)

• Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC

Results.

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.

Conclusion.

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC (Dangerous Substances Directive).

The test material did not meet the criteria for classifcation as a skin irritant according to EU CLP regulations.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 11 February 2008 and 21 February 2008.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

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)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: 21/8/2007. Date of signature: 15/10/2007

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (Certified Rabbit Diet) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 17 to 23°C.
- Humidity (%): The relative humidity was set to achieve limits of 30 to 70%.
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continous light and twelve hours darkness.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

Single application of test material (72 hours).

Observation period (in vivo):

72 hours.

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:
Immediately after administration of the test material, an assessment of the initial pain reaction was made.

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical Draize Scale for Scoring Ocular Irritation.

Any other ocular effects were also noted.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

: animal 67182

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

: animal 67215

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

: animal 67216

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

: animal 67182

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

mean

Remarks:

: animal 67215

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

mean

Remarks:

: animal 67216

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

: animal 67182

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

: animal 67215

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

: animal 67216

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

: animal 67182

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

: animal 67215

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

: animal 67216

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

No corneal or iridial effects were noted.

Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and in two treated eyes at the 24-hour observation.

One treated eye appeared normal at the 24-hour observation and the remaining two treated eyes appeared normal at the 48-hour observation.

Other effects:

Initial pain reaction: Slight initial pain in all animals.

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material produced the following individual mean scores for opacity, iritis redness and chemosis, as required for classification according to the Globally Harmonised classification Scheme:

Rabbit Number: 67182
Opacity: 0.0
Iritis: 0.0
Conjunctival redness: 0.0
Chemosis: 0.0

Rabbit number: 67215
Opacity: 0.0
Iritis: 0.0
Conjunctival redness: 0.3
Chemosis: 0.0

Rabbit number: 67216
Opacity: 0.0
Iritis: 0.0
Conjunctival redness: 0.3
Chemosis: 0.0

Based on these results the substance is not classified as an eye irritant.

Executive summary:

Introduction.

The study was performed to assess the irritancy potential of the test material ‘Distillates (Fischer-Tropsch), heavy, C18-50 - branched, cyclic and linear’ to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 April 2002)

• Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004173/EC

Result.

A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. One treated eye appeared normal at the 24-hour observation and the remaining two treated eyes appeared normal at the 48-hour observation.

The test material produced the following individual mean scores for opacity, iritis redness and chemosis, as required for classification according to the Globally Harmonised classification Scheme:

Rabbit Number: 67182

Opacity: 0.0

Iritis: 0.0

Conjunctival redness: 0.0

Chemosis: 0.0

Rabbit number: 67215

Opacity: 0.0

Iritis: 0.0

Conjunctival redness: 0.3

Chemosis: 0.0

Rabbit number: 67216

Opacity: 0.0

Iritis: 0.0

Conjunctival redness: 0.3

Chemosis: 0.0

The test material did not meet the criteria for classification as irritant according to Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No key or supporting data is available for docosane. However, key skin and eye irritation data is available from a structurally related substance, C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) and is presented below:

Dermal irritation:

The study was performed to assess the irritancy potential of the test material following a single, 4-hour, semi-occluded application to the intact rabbit skin. The method was designed to meet the requirements of OECD Guideline No. 404 "Acute Dermal Irritation/Corrosion" and Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC.

No evidence of skin irritation or corrosion was observed during the study in three animals.

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Eye irritation:

The study was performed to assess the irritancy potential of the test material following a single application to the rabbit eye. The method was designed to meet the requirements of OECD Guideline No. 405 "Acute Eye Irritation/Corrosion" and Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC.

A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. One treated eye appeared normal at the 24-hour observation and the remaining two treated eyes appeared normal at the 48-hour observation.

Justification for classification or non-classification

Dermal irritation:

Docosane does not meet the criteria for classifcation as a skin irritant according to EU CLP regulations.

Eye irritation:

The test material produced the following individual mean scores for opacity, iritis redness and chemosis, as required for classification according to the Globally Harmonised classification Scheme:

Rabbit Number: 67182

Opacity: 0.0

Iritis: 0.0

Conjunctival redness: 0.0

Chemosis: 0.0

Rabbit number: 67215

Opacity: 0.0

Iritis: 0.0

Conjunctival redness: 0.3

Chemosis: 0.0

Rabbit number: 67216

Opacity: 0.0

Iritis: 0.0

Conjunctival redness: 0.3

Chemosis: 0.0

Based on the read across data described above, docosane does not meet the criteria for classifcation as an eye irritant according to EU CLP regulations.