Docosane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study on supporting substance (with limited range, C8-26) was conducted according to OECD guideline and in compliance with GLP. Read-across considered to be reliability 2.

Justification for type of information:

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

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study on supporting substance (with limited range, C8-26) was conducted according to OECD guideline and in compliance with GLP. Read-across considered to be reliability 2.

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 source

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan laboratories, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: minimum 200 g
- Fasting period before study:
- Housing: solid floor polypropylene cages, furnished with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: not defined
- % coverage: ca. 10%
- Type of wrap if used: surgical gauze, semi-occluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was wiped with cotton wool, moistened with arachis oil BP
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.62 mL/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for deaths and overt signs of toxicity at 0.5, 1, 2, and 4 hours after dosing. Individual body weights were recorded prior to application of the test item on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: The test sites were examined for evidence of primary irritation and scored. The appearance of any macroscopic abnormalities were recorded at necropsy, no tissues were retained.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

There were no signs of systemic toxicity.

Body weight:

All animals showed expected gains in body weight.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Very slight erythema and crust formation and/or small superficial scattered scabs were noted at the test sites of four females. There were no signs of dermal irritation noted at the test sites of the remaining animals.

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

An LD50 value of >2000 mg/kg bw is reported in a reliable study conducted according to an OECD test guideline and in compliance with GLP.

Executive summary:

The acute dermal toxicity study is a reliable test performed with Distillates (Fischer-Tropsch), C8-26 – branched and linear, in accordance with OECD 402 and in compliance with GLP. 2000 mg/kg bw of test substance was applied to five male and five female Wistar rats for a twenty-four hour exposure period under semiocclusive conditions. The animals were observed for deaths or overt signs of toxicity, and the test sites were observed for primary irritation for fourteen days before sacrifice and necroscopy. No deaths occurred and no signs of overt toxicity were observed. There were no abnormalities noted at necroscopy. Very slight erythema and crust formation and/or small superficial scattered scabs were noted at the test sites of four females. There were no signs of dermal irritation noted at the test sites of the remaining animals.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Distillates (Fischer-Tropsch), C8-C26, branched and lniear

Cas Number:

848301-67-7

Molecular formula:

CnH2n+2

IUPAC Name:

Distillates (Fischer-Tropsch), C8-C26, branched and lniear

Constituent 2

Reference substance name:

Distillates (Fischer-Tropsch), C8-26, branched and linear

IUPAC Name:

Distillates (Fischer-Tropsch), C8-26, branched and linear

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan laboratories, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: minimum 200 g
- Fasting period before study:
- Housing: solid floor polypropylene cages, furnished with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: not defined
- % coverage: ca. 10%
- Type of wrap if used: surgical gauze, semi-occluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was wiped with cotton wool, moistened with arachis oil BP
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.62 mL/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for deaths and overt signs of toxicity at 0.5, 1, 2, and 4 hours after dosing. Individual body weights were recorded prior to application of the test item on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: The test sites were examined for evidence of primary irritation and scored. The appearance of any macroscopic abnormalities were recorded at necropsy, no tissues were retained.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

There were no signs of systemic toxicity.

Body weight:

All animals showed expected gains in body weight.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Very slight erythema and crust formation and/or small superficial scattered scabs were noted at the test sites of four females. There were no signs of dermal irritation noted at the test sites of the remaining animals.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

An LD50 value of >2000 mg/kg bw is reported in a reliable study conducted according to an OECD test guideline and in compliance with GLP.

Executive summary:

The acute dermal toxicity study is a reliable test performed with Distillates (Fischer-Tropsch), C8-26 – branched and linear, in accordance with OECD 402 and in compliance with GLP. 2000 mg/kg bw of test substance was applied to five male and five female Wistar rats for a twenty-four hour exposure period under semiocclusive conditions. The animals were observed for deaths or overt signs of toxicity, and the test sites were observed for primary irritation for fourteen days before sacrifice and necroscopy. No deaths occurred and no signs of overt toxicity were observed. There were no abnormalities noted at necroscopy. Very slight erythema and crust formation and/or small superficial scattered scabs were noted at the test sites of four females. There were no signs of dermal irritation noted at the test sites of the remaining animals.