Solsperse 22000-Wirksubstanz

Endpoint summary

Description of key information

In oral acute toxicity studies an LD50 of > 2000 mg/kg was determined in rats.

Dermal toxicity after single dermal application was tested in male and female rats. The LD50 value for acute dermal toxicity is >2,000 mg/kg bw.

Acute inhalation toxicity: Study was waived

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other: Annex V - method B.1

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

other: Rat (Wistar-derived)

Vehicle:

corn oil

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: > 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: > 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels:No significant signs of toxicity were observed

Gross pathology:

Effects on organs:No macroscopic abnormalities were detected at post mortem

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose of the substance was greater than 2000 mg/kg to both male and female rats.

Executive summary:

A group of 5 male and 5 female rats each received a single oral dose of 2000 mg/kg of the substance. The animals were assessed daily for any signs of systemic toxicity and their bodyweights were recorded at intervals.

No significant signs of toxicity were observed and none of the animals died. the test sample stained yellow the tail, coat and faeces of some of the animals.

The acute oral median lethal dose of the substance was greater than 2000 mg/kg to both male and female rats.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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:

Species Sprague Dawley rat
Strain HSD: Sprague Dawley SO
Origin HARLAN WINKELMANN Gartenstr. 27, 33178 Borchen SPF breeding colony
Body weight at start of study
male animals mean = 188 g (=100%); s = ± 7.1 g; n = 5
female animals mean = 187 g (= 100 %); s =±7.7g; n = 5
Age at the start of the study 6- 10 weeks

Animal maintenance in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5
Room temperature 22 ± 3°C
Relative humidity 50± 20%
Lighting time 12 hours daily
Acclimatization at least seven days
Food ssnif('1 R/M-H (V 1534), ad libitum
Withdrawal of food from about 16 hours before to 3- 4 hours after treatment
Water tap water in plastic bottles, ad libitum
Animal identification fur marking with KMn04 and cage numbering

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 days.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

Preliminary study:

Comprehensive description of clinical signs:
No symptoms were observed after administration of 2000 mglkg body weight.

Comprehensive description of macroscopic findings:
The animals killed at the end of the observation period showed no macroscopically visible changes.

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 whole study.

Clinical signs:

other: No symptoms were observed after administration of 2000 mg/kg body weight

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Other findings:

none

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on the results obtained in this acute oral toxicity study according to OECD TG 401 the median lethal dose value LD0 of the tets material for male and female rats is greater than 2000 mglkg body weight

Executive summary:

Acute oral toxicity testing of the test item in Sprague Dawley rats yielded a non-lethal dose (LD0) above 2000 mg/kg body weight in both male and female animals.

After administration of 2000 mg/kg body weight neither deaths nor symptoms occurred.

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

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

Reliability:

2 (reliable with restrictions)

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

other: Annex V method B.3

GLP compliance:

yes

Limit test:

yes

Species:

other: Rat (Wistar-derived)

Strain:

other: APfSD

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

other: Deionised water

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: > 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: > 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: There were no significant signs of systemic toxicity

Gross pathology:

Effects on organs:There were no treatment related findings at the post mortem examination

Other findings:

Signs of toxicity (local):The skin of all animals was stained orange/yellow for 6 days after application which prevented a full assessment of erythema. There was evidence of slight irritation at the application site of the majority of animals for up to 2 days after application

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

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

Executive summary:

A sample of test substance was assessed for its acute dermal toxicity using a limit version of the B.3 method.

 

Five male and five female rats each received a single dermal application of 2000 mg/kg of the test sample. The animals were assessed daily for any sighs of systemic toxicity and their bodyweights were recorded at intervals. At the end of the study, all the animals were killed and given a macroscopic post mortem examination.

 

None of the animals died and there were no significant signs of systemic toxicity. There were no treatment related findings at the post mortem examination.

 

During the study the test sample stained the application sites orange/yellow for 6 days after application which prevented a full assessment of erythema. However, there was evidence of slight skin irritation (oedema) for up to 2 days after application.

 

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

reliable

Additional information

Acute oral toxicity:

Acute toxicity after single oral application was tested in male and female rats, which received 2000 mg/kg bw (OECD and GLP guideline compliant study). No animals in these studies died. The LD50 value for acute oral toxicity is >2,000 mg/kg bw.

Acute dermal toxicity:

Dermal toxicity after single dermal application was tested in male and female rats, which received 2000 mg/kg bw (B.3 and GLP guideline compliant study). No animals in these studies died. The LD50 value for acute dermal toxicity is >2,000 mg/kg bw.

Acute inhalation toxicity:

Study was waived; substance is not classified for this endpoint. When aerosolized in respirable form, the substance is considered likely to behave like an inert dust.

Justification for classification or non-classification

no classification

In oral acute toxicity studies an LD50 of > 2000 mg/kg was determined in rats.

The LD50 value for acute dermal toxicity is >2,000 mg/kg bw.