Pivalic acid

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pivalic acid

EC Number:

200-922-5

EC Name:

Pivalic acid

Cas Number:

75-98-9

Molecular formula:

C5H10O2

IUPAC Name:

2,2-dimethylpropanoic acid

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:

other: 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.