Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Detailed publication

Data source

Reference
Reference Type:
publication
Title:
Approach to long-term effects of phosphorus trichloride
Author:
He Y, Yang X, Zhong X, Deng L & Zhang J
Year:
1989
Bibliographic source:
Weisheng Dulixue Zazhi 3, 37-40

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Developmental toxicity study
GLP compliance:
no
Remarks:
: published study
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorus trichloride
EC Number:
231-749-3
EC Name:
Phosphorus trichloride
Cas Number:
7719-12-2
Molecular formula:
Cl3P
IUPAC Name:
lambda6-phosphorus(3+) trichloride
Details on test material:
Phosphorus trichloride

Test animals

Species:
rat
Strain:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Days 6-15
Frequency of treatment:
Daily
Duration of test:
Animals were sacrificed on Day 20
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 0, 6.44, 9.7, 19.3 mg/kg bw
Basis:
actual ingested
Control animals:
other: positive + vehicle control groups
Details on study design:
Sex: female

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
19.3 mg/kg bw/day
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

Any other information on results incl. tables

Body weight gain of dams: 
No effects in treated animals; reduction in positive controls

Effects on fertility:    neg   low   med   hig   pos 
Number of pregnant rats: 16    15    15    14    15
number of fetuses:       136   126   132   124   141
Corpora lutea:           218   205   217   206   150
corpora lutea per rat:   13.6  13.7  14.5  14.7  10
number of pups/litter:   8.13  7.73  8.47  8.06  8.2

dead fetuses:            3     1     3     10    0
% dead fetuses:          2.3   0.79  2.27  8.06  0

resorptions:             3     9     2     1     67
% resorptions:           2.2   7.1   1.52  0.81  47.5*

litters with resorptions:3     3     1     1     11
% Litter w. resorptions:12.3  20     6.67 7.14  73.3*

* = significant

                         neg    low    med     hig     pos
pups examined:           130    116    127     113     74   
size (cm):               3,84   3.89   3.84    3.79    3,64
tail (cm):               1,29   1,29   1,25    1,25    1,13 
weight of placenta (g):  0,43   0,49   0,46    0,47    0,51
frontal fontanella (mm): 3,14   2,95   3,06    2,97    2,93

There were no significant differences between treated and negative control animals. No malformations were detected. Skeletal development in treated foetuses was retarded but without a dose effect relation. Positive controls showed clear effects on fertility indices but no malformations.

Applicant's summary and conclusion

Conclusions:
No evidence of developmentla toxicity or teratogenicity was seen under the conditions of this study.
Executive summary:

No evidene of teratogenicity or developmental toxicity was seen in rats administered phosphorus trichloride on Days 6 -16 of gestation.