2-(dimethylamino)ethyl acrylate

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

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

Principles of method if other than guideline:

Type: other: OECD combined study TG 422, combined repeat dose and reproductive/developmental (one generation) toxicity screening test
Method: other: OECD combined repeated dose and reproductive/developmental toxicity screening test

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%,

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:

males, 43 day
females, from 14 day before mating to day 3 of lactation

Frequency of treatment:

once daily

Doses / concentrations

Remarks:

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

Control animals:

yes, concurrent vehicle

Details on study design:

Duration of test: males; 43 day, females; from 14 day before mating to day 4 of lactation
- 54 day

Results and discussion

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 cellFinding in forestomach
                       +    #     #     #     7/7   #
 -Hyperplasia, mucosa ++    0     0     0     10**  1
 -Inflammatory cell inifiltration        
                      ++    0     0     0     10**  1
 -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
  successful mating               12        12        12     10
 -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 pairssuccess fulmating /
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 day 0  15.9        15.3        13.6   14.9        
 - Sex ratio (male/female)      0.97        0.91        1.14   0.89
 -Viability index on day 4 (%)  90.9        99.4        98.8   87.5        
 -Number of live pups on day 4  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