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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles: non-GLP
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles: non-GLP
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
only one dose tested
GLP compliance:
yes
Test type:
fixed dose procedure
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Sex: Males (5); Females (5)
- Weight at study initiation: Males (190-195 g), Females (194-205 g)
- Housing: individual
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
A single dose of MRD-77-10 (15 g/kg) was administered by oral gavage.
Doses:
15 g/kg
No. of animals per sex per dose:
Male (5), Female (5)
Control animals:
no
Details on study design:
The acute oral toxicity of MRD-77-10 was investigated in a group of 5 male and 5 female rats. Each animal received a single oral dose of 15 g/kg administered by oral gavage. The condition of all animals was observed over a 14 day period following dosing.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Mortality:
No mortality was observed in any of the animals treated with 15 g/kg MRD-77-10.
Clinical signs:
other: Hair loss of the urogenital region was noted in 4 males/5 females. Kidneys appeared darker then normal in 2 males and 3 females, but no pathology was noted. All animals gained weight through out the observational period.
Gross pathology:
Kidneys appeared darker then normal in 2 males and 3 females, but no pathology was noted.
Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LD50 for MRD-77-10 following oral gavage was >15 g/kg . Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

The acute toxicity of MRD-77-10 was evaluated in rats via oral gavage at a dose of 15 g/kg bw. Observations were made as to the nature, onset, severity, and duration of toxicological signs once per day for a total of 14 days. All animals survived the entire observational period and displayed a low incidence of clinical symptoms.  The LD50 for MRD-77-10 following oral gavage was >15 g/kg. Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
only one dose tested
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Constituent 1

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Sex: Males (5); Females (5)
- Weight at study initiation: Males (190-195 g), Females (194-205 g)
- Housing: individual

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
A single dose of MRD-77-10 (15 g/kg) was administered by oral gavage.
Doses:
15 g/kg
No. of animals per sex per dose:
Male (5), Female (5)
Control animals:
no
Details on study design:
The acute oral toxicity of MRD-77-10 was investigated in a group of 5 male and 5 female rats. Each animal received a single oral dose of 15 g/kg administered by oral gavage. The condition of all animals was observed over a 14 day period following dosing.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Mortality:
No mortality was observed in any of the animals treated with 15 g/kg MRD-77-10.
Clinical signs:
other: Hair loss of the urogenital region was noted in 4 males/5 females. Kidneys appeared darker then normal in 2 males and 3 females, but no pathology was noted. All animals gained weight through out the observational period.
Gross pathology:
Kidneys appeared darker then normal in 2 males and 3 females, but no pathology was noted.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LD50 for MRD-77-10 following oral gavage was >15 g/kg . Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

The acute toxicity of MRD-77-10 was evaluated in rats via oral gavage at a dose of 15 g/kg bw. Observations were made as to the nature, onset, severity, and duration of toxicological signs once per day for a total of 14 days. All animals survived the entire observational period and displayed a low incidence of clinical symptoms.  The LD50 for MRD-77-10 following oral gavage was >15 g/kg. Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.