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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline (402): (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 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
50, 200, 794, 3160 mg/kg
No. of animals per sex per dose:
4
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 160 mg/kg bw
Remarks on result:
other: 2 animals died within 48 hours post exposure
Mortality:
Two deaths were incurred in the 3160 mg/kg level at 24 and 48 hours postexposure, respectively.
Clinical signs:
Death was preceded by marked depression, severe dyspnea, prostration, excessive urination, coma.
Gross pathology:
Congestion of lungs, adrenals, kidneys, blanched areas on liver and spleen, inflammation of the bladder mucosa and gastrointestinal tract.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 for neopentanoic acid is 3160 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.
Executive summary:

In this study, groups of 4 rabbits were dermally exposed to neopentanoic acid at concentrations of 50, 200, 794, or 3160 mg/kg for 24 hours with a post exposure observation period of 14 days. The only animals that died were in the 3160 mg/kg dose group; 2 animals within 48 hours post exposure. The dermal LD50 for neopentanoic acid is 3160 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.