Propyl chloroformate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Study of Industrial Bio-Test Laboratories (IBT).

Remarks:

A routine inspection by FDA at Industrial Bio-Test laboratories (IBT) in 1976 uncovered numerous discrepancies between raw data and study reports, and gross deficiencies in study conduct; mainly in non-acute studies, but also in acute toxicity studies. Thus, study reports from IBT between the 1960´s and until 1978 should be taken with care. An important consideration is the consistency of the findings from the IBT study with findings from other studies that were conducted at reputable test houses at a later date to the IBT study (to rule out the possibility of data being manipulated by IBT to be consistent with existing data). REFERENCE: OECD (2005): Manual for investigation of HPV Chemicals, Chapter 3: Data Evaluation (3.1 Guidance for Determining the Quality of Data fo the SIDS Dossiers: Reliability, relevance and adequacy, 3.1.8 Acceptance and use of studies from Industrial Bio-Test laboratories. OECD - Manual for the Assessment of Chemicals (http://www.oecd.org/chemicalsafety/risk-assessment/chapter3dataevaluation.htm)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Only two animals/sex/group

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propyl chloroformate

EC Number:

203-687-7

EC Name:

Propyl chloroformate

Cas Number:

109-61-5

Molecular formula:

C4H7ClO2

IUPAC Name:

propyl carbonochloridate

Details on test material:

clear, colorless liquid

Test animals

Species:

rabbit

Strain:

other: New Zealand

Sex:

male/female

Details on test animals or test system and environmental conditions:

2.3 - 3.2 kg bw at start of study

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Backs of rabbits shaved 24 hours prior to exposure

Duration of exposure:

24 hrs

Doses:

6.8 and 10.2 g/kg bw

No. of animals per sex per dose:

2/sex/group

Control animals:

no

Details on study design:

14 day observation period. Body weights, local skin reactions, clinical signs and necropsy for all animals.

Statistics:

Litchfield and Wilcoxon

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 10.2 other: g/kg bw

Mortality:

There were no deaths at 6.8 g/kg bw. Two animals (one male on day 11, one female on day 4) died at 10.2 g/kg bw.

Clinical signs:

other: The animals in both dose groups were hypoactive within 2-3 days of exposure and did not recover. Severe irritation and edema and burns were observed at the end of the 24 hr exposure period. Six days later the skin was necrotic.

Gross pathology:

Hyperemia of the kidneys and necrosis of the skin at the site of contact.