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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:
From November 14, 1994 To January 5, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to OECD guideline 401: GLP.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From November 14, 1994 To January 5, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to OECD guideline 401: GLP.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
5000 mg/kg: 0 males; 0 females
Clinical signs:
Ano-genital staining, observed at the 6 hour interval, was the only remarkable clinical in-life observation.
Body weight:
All surviving animals displayed increases in body weight over their Day 0 values.
Gross pathology:
All animals were free of abnormalities at postmortem examination.
Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for MRD-83-205 is >5000 mg/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:

This data is being read across from the source study that tested Hydrocarbons, C10-C12, isoalkanes, <2% aromatics based on analogue read across.

MRD-83-205 was administered via oral intubation to 5 male and 5 female rats at a dose of 5000 mg/kg to assess acute oral toxicity.  Animals were observed daily for 14 days post dosing.  No overt signs of toxicity were apparent.  All animals survived to study termination. All animals were free of abnormalities at postmortem examination.  All surviving animals displayed increases in body weight over their day 0 values.  The acute oral LD50 for MRD-83-205 is >5000 mg/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:
1995
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Constituent 1
Reference substance name:
Hydrocarbons, C10-C12, isoalkanes, <2% aromatics
EC Number:
923-037-2
Molecular formula:
(CH2)6-8C4H10
IUPAC Name:
Hydrocarbons, C10-C12, isoalkanes, <2% aromatics
Details on test material:
- Name of test material (as cited in study report): MRD-83-205
- Physical state: liquid
- Density: 0.76 g/mL at 70oF
- Analytical purity: assumed to be 100%
- Stability under test conditions: Material stable under normal conditions
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms
- Age at study initiation: Approximately 10-11 weeks
- Weight at study initiation: 195 to 282 grams
- Housing: 5 per cage
- Diet (e.g. ad libitum): ad libitum, Purina Rodent Chow
- Water (e.g. ad libitum):ad libitum
- Acclimation period:21days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained range 20-24.4
- Humidity (%): maintained range 40-70
- Photoperiod (hrs dark / hrs light): 12hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Undiluted test material was administered by a single oral intubation via syringe and a No. 13 ball tipped feeding needle.
Doses:
5000mg/kg
No. of animals per sex per dose:
10 animals per dose (5 male; 5 female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made as to the nature, onset, severity, and duration of toxicological signs at 1, 2, 4, and 6 hours after dosing, and once per day thereafter for a total of 14 Days. Body weights were recorded on the day prior to dosing (pretest), the day of dosing (Day 0), on Day 7, and on Day 14, and at death for those which succumbed.
- Necropsy of survivors performed: yes
Statistics:
The means and standard deviations of the body weights and body weight changes, by sex and group were calculated .

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
5000 mg/kg: 0 males; 0 females
Clinical signs:
Ano-genital staining, observed at the 6 hour interval, was the only remarkable clinical in-life observation.
Body weight:
All surviving animals displayed increases in body weight over their Day 0 values.
Gross pathology:
All animals were free of abnormalities at postmortem examination.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for MRD-83-205 is >5000 mg/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:

MRD-83-205 was administered via oral intubation to 5 male and 5 female rats at a dose of 5000 mg/kg to assess acute oral toxicity.  Animals were observed daily for 14 days post dosing.  No overt signs of toxicity were apparent.  All animals survived to study termination. All animals were free of abnormalities at postmortem examination.  All surviving animals displayed increases in body weight over their day 0 values.  The acute oral LD50 for MRD-83-205 is >5000 mg/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.