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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles: pre-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-64-1
- Substance type: white crystalline powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
34.6, 120, 417, 1450, 5000, 10000
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
95% CL:
830 - 4 820
Clinical signs:
1450 mg/kg - slight to marked depression, dyspnea and ataxia at 24 hours, and death within 48 hours postdose. survivors showed depression, severe dyspnea, depressed reflexes, sprawling, incoordination, and abnormal gait.

5000 and 10000 mg/kg - depression, dyspnea, ataxia, and sprawling of limbs within one hour postdose. Marked depression, severe dyspnea and prostration preceded death in all animals within one to 48 hours.
Gross pathology:
5000 and 10000 mg/kg - congestion of lungs, liver, kidneys, and adreneals; pyloric portion of the stiach grossly hemorrhagic.

Any other information on results incl. tables

Time of Death (post-exposure)
Dose (mg/kg-bw) 1 h 4 h 24 h 2 days 3 days 4 days 5-14 days
34.6 0/5 0/5 0/5 0/5 0/5 0/5 0/5
120 0/5 0/5 0/5 0/5 0/5 0/5 0/5
417 0/5 0/5 0/5 0/5 0/5 0/5 0/5
1450 0/5 0/5 0/5 2/5 2/5 2/5 2/5
5000 0/5 0/5 3/5 5/5
10000 2/5 2/5 5/5

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for neopentanoic acid is 2000 mg/kg. This finding warrants the classification of neopentanoic acid as not classified as an acute toxon under EU GHS guidelines and does not warrant classification under the EU requirements for dangerous substances and preparations guidelines.
Executive summary:

In this study, male rats were administed neopentanoic acid at doses of 34.6, 120, 417, 1450, 5000, or 10000 via oral gavage. Based on mortality, the estimate LD50 is 2000 mg/kg. This finding warrants the classification of neopentanoic acid as not classified as an acute toxin under EU GHS guidelines and does not warrant classification under the EU requirements for dangerous substances and preparations guidelines.