[No public or meaningful name is available]

Endpoint summary

Description of key information

Acute toxicity after single oral application was tested in female rats, which received 2000 mg/kg bw (2 x 3 females). All animals survived until the end of the study without showing any signs of toxicity. Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed. The LD50 value for acute oral toxicity is > 2000 mg/kg bw.

A single dermal application of the test item to 10 rats (5 males and 5 females) at a dose of 2000 mg/kg bw was associated with no mortality and neither clinical signs. The dermal LD50 was determined to be > 2000 mg/kg bw

The studies were carried out according to OECD guidelines 423 and 402.

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:

June 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

Adopted 17 Dec. 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 177 +/- 6.7 g
- Fasting period before study: yes
- Housing: transparent macrolon cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 10. June To: 25. June 2003

Route of administration:

oral: gavage

Vehicle:

other: Tylose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 %
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: homogenity, stability

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual):
the test item was suspended in tylose and distributed homogeneously by means of a magnetic stirrer

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to toxicity data of related compounds

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 (2 x 3 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Symptoms: twice daily
Body weight: weekly
- Necropsy of survivors performed: yes

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred

Clinical signs:

Feces was discolored by compound one day after the administration, no symptoms of toxicity were observed

Body weight:

not impaired

Gross pathology:

no macroscopically visible changes

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this OECD 423 study with female rats the LD50 of the test item is greater than 2000 mg/kg bw.

Executive summary:

Acute oral testing of the test item in famels rat yielded a LD50 greater than 2000 mg/kg be. After administration of 2000 mg/kg bw neither deaths nor symptoms occurred. Only the feces was discolored by the test compound on day 2 of the study. Development of body weight was not impaired. All animals were killed at the end of the observation period. They showed no macroscopically visible changes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

reliable without restriction

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:

Jun - Jul 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Adopted July 31, 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

Adopted Feb 24, 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation:
males: 259 +/- 5.6 g
females: 223 +/- 9.3 g
- Fasting period before study:no, not required
- Housing: in transparent macrolon cages (type III) on soft wood granulate in air-conditioned room, 1 animal per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 25. June To: 9. July 2003

Type of coverage:

occlusive

Vehicle:

other: moistened with tylose

Details on dermal exposure:

TEST SITE
- Area of exposure: 6x8 cm
- % coverage: 100
- Type of wrap if used: ealstic plaster bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (0.5 g test item moistend with 0.5 mL tylose)
- For solids, paste formed: yes, moistned with 0.5 mL tylose

VEHICLE
- Amount(s) applied (volume or weight with unit): tylose

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, twice daily

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study

Clinical signs:

No symptoms were observed.
The male animals showed reddish discolored skin one day after treatment, when the bandage was removed. Females showed reddish discolored skin on day 1 and 2 after treament.

Body weight:

Development of body weight was not impaired. One of five females showed a slight loss of body weight in the first study week, but body weight gain was nomalised in the second week.

Gross pathology:

no macroscopically visible changes reported

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the reesults obtained in this study the LD50 (dermal) of the test item for male and female rats is greater than 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity testing of the test item yielded a LD50 > 2000 mg/kg bw in both male and femal animals. After administration of 2000 mg/kg w neither deaths nor symptoms occurred. The male animals showed reddish discolored akin one day after treatment when the bandage was removed. Females showed reddish discolored skin on day 1 and 2 after treatment. Development of body weight was not impaired in male animals. One of five females showed a slight body weigth loss in the first study week, but body weight gain normalised in the second study week. No animal showed macroscopically visible changes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

reliable without restriction

Justification for classification or non-classification

Due to the results described in the acute oral and dermal toxicity studies (LD₅₀oral/dermal in rats > 2000 mg/kg bw) the substance does not have to be classified as acute toxic.