H112323

Endpoint summary

Description of key information

The available data for test substance indicates a low potential for acute oral (LD50 >2,000 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw). 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apr-Mar, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted equivalent or similar to EU Method B.1. and OECD Guideline 401 in compliance with GLP

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Crl:(WI)BR strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited, Manston Road, Margate, Kent, UK
- Age at study initiation: 7-8 wk males and 9-10 wk females
- Weight at study initiation: 176-198 g (males) and 191-212 g (females)
- Fasting period before study: Yes, 24 h
- Housing: Suspended cages (26.5cm x 50.0cm x 20.7cm) made of stainless steel, one side being solid and the remainder wire mesh
- Diet (e.g. ad libitum): Porton Combined Diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 6 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2 °C
- Humidity (%): 55±25 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): Test substance was suspended in corn oil. The volume of the dose was calculated for each animal according to its weight at the time of dosing, and was adjusted for water content,

Doses:

2000 mg/kg bw (adjusted for water content)

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded once within 2 h of dosing and again between 4 and 7 h after dosing on the day of dosing and there after once a day up to Day 15. The animals were weighed on Day -1, 1 3, 4, 8 and 15.
- Necropsy of survivors performed: yes; animals were killed by inhalation of excessive levels of halothane vapour followed by exsanguination

Statistics:

No data

Preliminary study:

No data

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: -

Mortality:

No mortalities occurred during the whole study.

Clinical signs:

other: There were no significant signs of toxicity

Gross pathology:

No significant gross pathology changes observed

Other findings:

No data

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the acute oral medial lethal dose (LD50) of the test substance was found to be >2,000 mg/kg in male and female wistar rats.

Executive summary:

A study was conducted to assess the acute oral toxicity of test substance in wistar rats equivalent or similar to EU Method B.1. and OECD guideline 401 in compliance with GLP.

A group of five male and five female rats received a single oral dose of 2000mg/kg (adjusted for water content) of the test sample as a preparation in corn oil. The animals were assessed daily for any signs of toxicity and their bodyweights were recorded at intervals.

None of the animals died and there were no significant signs of toxicity. There were no treatment-related abnormalities at post mortem examination. The acute oral median lethal dose was in excess of 2000mg/kg to male and female rats.

Under the test conditions, the acute oral medial lethal dose (LD50) of the test substance was found to be >2,000 mg/kg in male and female wistar rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apr-Mar, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted equivalent or similar to EU Method B.3. and OECD Guideline 402 in compliance with GLP

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Crl:(WI)BR strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited, Manston Road, Margate, Kent, UK
- Age at study initiation: 7-8 wk males and 9-10 wk females
- Weight at study initiation: 184-195 g (males) and 199-221 g (females)
- Fasting period before study: Yes, 24 h
- Housing: Suspended cages (26.5cm x 50.0cm x 20.7cm) made of stainless steel, one side being solid and the remainder wire mesh
- Diet (e.g. ad libitum): Porton Combined Diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 6 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorso-lumbar area
- Type of wrap if used: The gauze patch was then covered by a patch of plastic film (7.5cm x 5cm) and was held in position using adhesive bandage (25cm x 5cm). This was secured by two pieces of PVC tape (approximately 2.5cm x 20cm) wrapped around the animal

REMOVAL OF TEST SUBSTANCE
- Washing (if done): using clean swabs of absorbent cotton wool soaked in clean warm water and was then dried gently with clean tissue paper
- Time after start of exposure: 24 h

TEST MATERIAL
- Concentration (if solution): Appropriate amount of test substance was moistened with 0.3 mL deionized water
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 mL deionized water.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded once within 4 h of dosing and then after once daily day up to Day 15. The animals were weighed on Day 1, 3, 4, 8 and 15.

- Necropsy of survivors performed: yes; animals were killed by inhalation of excessive levels of halothane vapour followed by exsanguination

Statistics:

No data

Preliminary study:

Not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: -

Mortality:

No mortalities occurred during the whole study.

Clinical signs:

other: No symptoms were observed after administration of 2000 mg/kg body weight. Signs of skin irritation consisting of slight to moderate or extreme erythema and slight or moderate oedema, were seen in all animals for 2 d after dosing. Scabs were also observed

Gross pathology:

No gross pathological changes were observed


No significant gross pathology changes observed

Other findings:

The test substance caused slight to moderate or extreme local skin irritation.

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the acute dermal medial lethal dose (LD50) of the test substance was found to be >2,000 mg/kg in male and female wistar rats.

Executive summary:

A study was conducted to assess the acute dermal toxicity of test substance in wistar rats equivalent or similar to EU Method B.3. and OECD guideline 402 in compliance with GLP.

A group of five male and five female rats received a single dermal dose of 2000mg/kg (adjusted for water content) of the test sample as supplied. The animals were assessed daily for any signs of toxicity and their bodyweights were recorded at intervals.

None of the animals died and there were no significant signs of toxicity. There were no treatment-related abnormalities at post mortem examination. Signs of slight to moderate or severe irritation were seen in all animals but all signs of irritation had disappeared by Day 5.

The acute dermal median lethal dose was in excess of 2000mg/kg to male and female rats.

Under the test conditions, the acute dermal medial lethal dose (LD50) of the test substance was found to be >2,000 mg/kg in male and female wistar rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Oral

A study was conducted to assess the acute oral toxicity of test substance in wistar rats equivalent or similar to OECD guideline 401 and EU Method B.1.

A group of five male and five female rats received a single oral dose of 2000 mg/kg (adjusted for water content) of the test sample as a preparation in corn oil. The animals were assessed daily for any signs of toxicity and their bodyweights were recorded at intervals.

None of the animals died and there were no significant signs of toxicity. There were no treatment-related abnormalities at post mortem examination. The acute oral median lethal dose was in excess of 2000 mg/kg to male and female rats.

The acute oral medial lethal dose (LD50) of the test substance was found to be >2000 mg/kg in male and female wistar rats (Parr-Dobrzanski R J & Leah AM, 1991).

 

Dermal

 

A study was conducted to assess the acute dermal toxicity of test substance in wistar rats equivalent or similar to OECD guideline 402 and EU Method B.3.

A group of five male and five female rats received a single dermal dose of 2000 mg/kg (adjusted for water content) of the test sample as supplied. The animals were assessed daily for any signs of toxicity and their bodyweights were recorded at intervals.

None of the animals died and there were no significant signs of toxicity. There were no treatment-related abnormalities at post mortem examination. Signs of slight to moderate or severe irritation were seen in all animals but all signs of irritation had disappeared by Day 5. The acute dermal median lethal dose was in excess of 2000 mg/kg to male and female rats.

The acute dermal medial lethal dose (LD50) of the test substance was found to be >2000 mg/kg in male and female wistar rats (Parr-Dobrzanski R J & Leah AM, 1991).

Justification for classification or non-classification

The available data for test substance indicates a low potential for acute oral (LD50 >2,000 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw) and does not meet the requirement for classification according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).