2-(dimethylamino)ethyl acrylate

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Remarks:

based on generations indicated in Effect levels (migrated information)

Adequacy of study:

other information

Data source

Reference

Title:

No information

Author:

Ministry of Health and Welfare, Japan(1997a): Toxicity Testing Reports of Environmental chemicals, vol.5, 583-594, "Combined Repeat Dose and Reproductive/Developmental|Toxicity Screening Test of 2-(Dimethylamino)ethyl acrylate by Oral Administration in Rats"

Materials and methods

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

IUCLID4 Test substance: other TS: Purity 99.9%, NIPPON SHOKUBAI CO.,LTD., Lot No. 5P07

TS-Freetext:
SOURCE: NIPPON SHOKUBAI CO.,LTD. Lot No. 5P07
PURITY: 99.9 wt%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Duration of treatment / exposure:

Exposure period: males, 43 day; females, from 14 day before mating to day 3 of lactation
Premating exposure period (males): 14 day
Premating exposure period (females): 14 day
Duration of test: males; 43 day, females; from 14 day before mating to day 4 of lactation- 54 day

Frequency of treatment:

once daily

Doses / concentrations

Remarks:

Doses / Concentrations:
0(Vehicle), 4, 20, 100 mg/kg/day
Basis:

Control animals:

yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:

NOAEL

Effect level:

100 mg/kg bw/day

Results: F1 generation

Effect levels (F1)

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

100 mg/kg bw/day

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

RS-Freetext:
For reproduction toxicity
NOAELs: = 100 mg/kg/day for males
          = 100 mg/kg/day for females
          = 100 mg/kg/day for F1 offsprings
2-(dimethylamino)ethyl acrylate had no effects on reproductive parameters  such as the mating index, the fertility index, number of corpora lutea or  implantations, the implantation index, the gestation index, the delivery  index, gestation length, parturition or maternal behavior.  On  examination of neonates, these were no significant differences in number  of offspring or live offspring, the sex ratio, the live birth index, the  viability index or body weight.  No abnormal findings ascribable to the  compound were found for external features, clinical signs or necroscopy  of the offspring.

- Female:
  At 100 mg/kg/day, 2 females out of 12 died.
  - By the observation, a decrease in the absolute thymus weight was  observed.
  - By the necroscopy examination, similar changes as males were observed.
  - By the histopathological examination, similar changes as males were  observed.
  At 20 mg/kg/day and 4 mg/kg/day, no effects were observed.

Female:
Dose [mg/kg/day]       Note   0     4    20   100  100
                                                  (dead)
--------------------  ------ ---   ---  ----  ---  -----
No. of animals               12    12   12    10    2
Findings in Lymph node
(pancreatico-duodenal)
-Hyperplasia, plasma    +     #     #    #    7/7   #
 cell
Finding in forestomach
-Hyperplasia, mucosa    ++    0     0    0    10**  1
-Inflammatory cell      ++    0     0    0    10**  1
 inifiltration
-Ulcer                  ++    0     0    0     9**  1
--------------------------------------------------------
Reproductive parameters:
- Dose [mg/kg/day]            0     4    20   100
  ------------------------------------------------------
-Number of pairs examined    12    12    12    11#
-Number of pairs with        12    12    12    10
 successful mating   
-Mating index (%)           100   100   100   100
-Number of pregnant females  11    11    11     9
-Fertility index (%)         91.7  91.7  91.7  90.0
-Pairing days until mating    2.0   2.1   2.0   3.6
-Number of estrous stages 
 without mating               0     0     0     0
--------------------------------------------------------
Mating index (%) = (No. of pairs with successful mating /
                    No. of pairs examined) x 100
Fertility index (%) = (No. of pregnant animals / No. of
                   pairs with successful mating) x 100

Developmental parameters:
Dose [mg/kg/day]              0     4    20   100
----------------------------------------------------
-Number of females examined  11    11    11     8
-Live birth index (%)        98.6  99.4  98.7  95.1
-Number of pups delivered    16.2  15.4  13.8  15.8
-Number of live pups on day0 15.9  15.3  13.6  14.9
- Sex ratio (male/female)     0.9  70.9  11.1  40.89
-Viability index on day 4(%) 90.9  99.4  98.8  87.5
-Number of live pups on day4 14.4  15.2  13.5  13.4
-Body weight gain of pups [g]
 day 0 to 4 male              4.3   4.3   4.2   3.8
            female            4.2   4.3   4.2   3.7
----------------------------------------------------
Live birth index (%) = (No. of live pups on day 0 / No. of
                       pups delivered) x 100
Viabitity index (%) = (No. of live pups on day 4 / No. of
                       pups on day 0) x 100