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Description of key information

The acute oral and dermal toxicity study resulted in LD50 value of >2000 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: male7-8 weeks; female 9 weeks
- Fasting period before study: 16 hours prior to treatment
- Weight at study initiation: male ca 175 g; female ca 161 g
- Housing: in groups of 5
- Diet ad libitum
- Water . ad libitum
- Acclimation period: at keast 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Single oral application of 2000 mg/kg bw by gavage
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 (5 males and 5 females)
Control animals:
no
Details on study design:
single oral application by gavage and observation of the animals for mortality, clinical signs and body weight development for 14 days. After termination the animals were examened gross-pathologically
Statistics:
the LD 50 was calculated according to the Method of "Moving averages" (Spärman and Kärber)
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: treatment was tolerated without mortality
Mortality:
0/10
Clinical signs:
no clinical signs
Body weight:
all animals gained weight
Gross pathology:
no gross pathological findings
Interpretation of results:
GHS criteria not met
Conclusions:
The acute toxicity of the test substance was evaluated according to the OECD TG 401 and GLP. 2000 mg/kg bw was applied to groups of 5 male and 5 female Wistar rats by gavage. No mortality occurred and no clinical signs were observed during the 14 -day observation period. Gross pathological examination after termination of the study did not show any findings which could be attributed to treatment. Thus. the LD50 is >2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Executive summary:

The acute toxicity of the test substance was evaluated according to the OECD TG 401 and GLP. 2000 mg/kg bw was applied to groups of 5 male and 5 female Wistar rats by gavage. No mortality occurred and no clinical signs were observed during the 14 -day observation period. Gross pathological examination after termination of the study did not show any findings which could be attributed to treatment. Thus. the LD50 is >2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
The available study was performed according to the respective guideline under GLP conditions and is evaluated with Klimisch score 1.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: OECD TG 402 and EEC Directive 440/2008 Part B, Method B.3
GLP compliance:
yes
Test type:
standard acute method
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-13 weeks
- Weight at study initiation: males: 269-276g; females: 233-256 g
- Fasting period before study:
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
2000 mg/kg bw was applied onto the shorn back of 5 male and 5 female rats and held in place by semi-occlusive dressing The treatment time was 24 hours. After removing of the dressing the treated area was rinsed. The animals were observed for clinical signs and mortality over a period of 14 days.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
2000 mg/kg bw was applied onto the shorn back of 5 male and 5 female rats and held in place by semi-occlusive dressing The treatment time was 24 hours. After removing of the dressing the treated area was rinsed. The animals were observed for clinical signs and mortality over a period of 14 days.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no animal died, none showed any reaction on treatment
Mortality:
No animal died
Clinical signs:
No clinical signs were observed
Body weight:
Body weight development was not affected by treatment
Gross pathology:
No grosspathological findings
Interpretation of results:
GHS criteria not met
Conclusions:
Bayscript Blaukomponente (konserviert) was applied dermally to the shorn back and flank of groups of male and female Wistat rats at a dose of 2000 mg/kg bw under semi-occlusive conditions (OECD TG 402). After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. The dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities or toxcolological relevant clinical signs. No adverse effects on body weight development in males and females nor gross pathological findings were observed. Thus, the LD50( rat, dermal) is > 2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Executive summary:

Bayscript Blaukomponente (konserviert) was applied dermally to the shorn back and flank of groups of male and female Wistat rats at a dose of 2000 mg/kg bw under semi-occlusive conditions (OECD TG 402). After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. The dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities or toxcolological relevant clinical signs. No adverse effects on body weight development in males and females nor gross pathological findings were observed. Thus, the LD50( rat, dermal) is > 2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
The available study was performed according to the respective guideline under GLP conditions and is evaluated with Klimisch score 1.

Additional information

ORAL ROUTE

The acute toxicity of the test substance was evaluated according to the OECD TG 401 and GLP. 2000 mg/kg bw was applied to groups of 5 male and 5 female Wistar rats by gavage. No mortality occurred and no clinical signs were observed during the 14 -day observation period. Gross pathological examination after termination of the study did not show any findings which could be attributed to treatment. Thus the LD50 is >2000 mg/kg bw.

DERMAL ROUTE

Bayscript Blaukomponente (konserviert) was applied dermally to the shorn back and flank of groups of male and female Wistar rats at a dose of 2000 mg/kg bw under semi-occlusive conditions (OECD TG 402). After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry. The dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities or toxicolological relevant clinical signs. No adverse effects on body weight development in males and females nor gross pathological findings were observed. Thus, the LD50( rat, dermal) is > 2000 mg/kg bw

INHALATION.ROUTE

There is no data on acute toxicity available using the inhalation exposure route. According to Regulation (EC) No. 1907/2006 (REACH) ANNEX VIII Column 2 in addition to the acute toxicity using the oral route for substances other than gases at least the acute toxicity data for one other route should be provided. This recommendation is fulfilled because there is an acute toxicity study available using the dermal route which is performed according to the respective OECD Guideline under GLP conditions and evaluated with Klimisch score 1. Thus, there is no need to conduct an acute inhalation toxicity study.


Justification for classification or non-classification

The acute oral and dermal toxicity study resulted in LD50 value of >2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.