2-chloroacetamide

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1968

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: The study was not conducted according to international guidelines for testing methods and GLP. Test substance was only given once and limited details are available, therefore the study is not reliable, relevant and adequate for classification.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1967

Materials and methods

Principles of method if other than guideline:

Single application during gestation.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-chloroacetamide

EC Number:

201-174-2

EC Name:

2-chloroacetamide

Cas Number:

79-07-2

Molecular formula:

C2H4ClNO

IUPAC Name:

2-chloroacetamide

Test material form:

solid: crystalline

Details on test material:

Chloroacetamide, purity / lot number not defined

Test animals

Species:

rat

Strain:

Long-Evans

Details on test animals or test system and environmental conditions:

The female virginal rats were weighing between 150 and 200 gm.
The animals were kept constantly on a breeding diet, characterized by high protein content, vitamin supplement, and
twice a week fresh lettuce.

Administration / exposure

Route of administration:

intraperitoneal

Details on exposure:

Note: the LD50 of chloroacetamide had been found to be 50 mg/kg given i.p.
Two groups of experimental rats were employed, receiving a 20 mg/kg on either in one or in two separate doses.

Duration of treatment / exposure:

diaplacentar

Frequency of treatment:

1x or 2x

Duration of test:

Single dose on day 7 or on days 11 and 12 of gestation,
The date of sperm finding in the vagina was designated as day zero. The blastocysts implant on the morning of the 5th
day, and parturition takes place on the 22nd gestation day (g.d). In order to avoid loss by cannibalism of placenta and
fetuses the animals were sacrificed under ether anesthesia on the 21st g.d. The uteri were removed in toto, implantation
sites counted, placentas and fetuses weighed and measured and fixed in formalin

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
20 mg/kg bw
Basis:
actual ingested
day 7 of gestation

Doses / concentrations 2

Remarks:

Doses / Concentrations:
20 mg/kg bw
Basis:
actual ingested
day 11 & 12 of gestation

No. of animals per sex per dose:

Groups of 20-40 run at regular intervals.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Details on maternal toxic effects:
No effect on the fetuses or litter were noted in both groups,

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

20 mg/kg bw/day (nominal)

Based on:

act. ingr.

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

No effect on the fetuses or litter were noted, indicating a lack of toxicity and lack of differential toxicity between mother and fetus.

Executive summary:

Cited from the German BG Chemie's tox. evaluations (2000):

"When chloroacetamide (LD50 intraperitoneal 50 mg/kg body weight) was administered intraperitoneally to pregnant Long-Evans rats at 20 mg/kg body weight either as a single dose on day 7 or on days 11 and 12 of gestation and caesarean section was performed in both groups on day 21 of gestation, assessment of implantations, placental weights, foetal weights and foetal malformations revealed no cases of embryotoxicity or teratogenicity. Moreover the dams showed no signs of toxicity (no further details).