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Diss Factsheets

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2021
Reliability:
1 (reliable without restriction)

Data source

Reference
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Plastic, waste, pyrolized, fractionation bottoms
EC Number:
942-177-5
Molecular formula:
Not available, UVCB substance
IUPAC Name:
Plastic, waste, pyrolized, fractionation bottoms
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day
Dose / conc.:
250 mg/kg bw/day
Dose / conc.:
500 mg/kg bw/day
Dose / conc.:
1 000 mg/kg bw/day
No. of animals per sex per dose:
Group1-Control: 12 males, 12 females
Group 2-Low dose: 12 males, 12 females
Group 3-Intermediate dose: 12 males, 12 females
Group 4 - High dose: 12 males, 12 females
Group 1S - Control: 5 males, 5 females
Group 4S - High dose: 5 males, 5 females

Total number of animals received 128 (64 males and 64 females )

Total number of animals used 116 (58 males and 58 females)
(Females were nulliparous and non-pregnant)
Control animals:
yes

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not examined

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed
Description (incidence and severity):
No treatment-related effects were detected on mating performance. All the female animals of control, low, intermediate and high dose groups showed positive evidence of mating. No significant difference was observed in the pre-coital interval of female animals between control, low, intermediate and high dose group.
Oestrous cyclicity was checked for all the female animals. Regular oestrous cycle was observed in all the animals of different groups in the study
Reproductive function: sperm measures:
not examined
Reproductive performance:
no effects observed
Description (incidence and severity):
Mating index for all the groups was 100 % (as confirmed by presence of sperm in the vaginal smear).
The two Dam each from control (G1- 0 mg/kg body weight) and high dose (1000 mg/kg/day) and one Dam each from low (G2- 250 mg/kg body weight) and intermediate (G3-500 mg/kg body weight) groups was observed non pregnat.
The pregnancy index for control (G1- 0 mg/kg body weight), low (G2-250 mg/kg body weight), intermediate (G3-500 mg/kg body weight) and high (G4-1000 mg/kg body weight) was found to be 83.3, 91.7, 91.7 and 83.3, respectively.

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
reproductive function (oestrous cycle)
reproductive function (sperm measures)
reproductive performance

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Description (incidence and severity):
No significance changes were observed in post natal losses in the entire treated group in both the sexes.
Of the litters delivered, in all the treatment groups, litter size at birth and subsequently on Day 1 and 4 post-partum were comparable to controls. No significant difference in the live birth was noted between control and treated groups. No nipple retention was found in any of the male litter from vehicle control, low, intermediate and high dose groups.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
Offspring body weight on day 1, day 4 and 13 were recorded. No significant differences observed in body weight on day 1 and day 13 was observed in low dose group (G2- 250 mg/kg body weight), intermediate (G3- 500 mg/kg body weight) and high dose group (G4- 1000 mg/kg body weight) when compared with control (G1- 0 mg/kg body weight) group.
Sexual maturation:
not examined
Anogenital distance (AGD):
no effects observed
Description (incidence and severity):
Offspring body weight on day 1, 4 and 13 were recorded. Significant change was observed on day 1 of intermediate (G3-500 mg/kg body weight) and high dose (G4-1000 mg/kg body weight) revealed decreased and increased respectively in both the sexes. Decreased significance observed on day 4 and 13 in low dose (G2-250 mg/kg body weight) and intermediate dose (G3-500 mg/kg body weight) in both the sexes when compared with vehicle control group) and could not be attributed to test item administration and no any biological evidant.
No significant differences in the anogenital distances (AGD) between control (G1- 0 mg/kg body weight and treated animals in low (G2- 250 mg/kg body weight), intermediate (G3- 500 mg/kg body weight) and high (G4- 1000 mg/kg body weight dose group of animals.

Effect levels (F1)

Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
> 1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs

Overall reproductive toxicity

Key result
Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
The administration of TACOIL to Wistar rats by oral gavage, at dose levels of 0, 250, 500 and 1000 mg/kg/day, resulted no treatment-related clinical signs in high dose group, changes in the body weights, feed consumption in high dose group. No treatment-related effects on reproduction/ development such as mating index, fertility index, gestation length, post-natal loss, sex ratio and offspring growth and development.
Macroscopic examination revealed no test item related findings in any of the animals of 250, 500 and 1000 mg/kg as well as in high dose satellite group treated at 1000 mg/kg. No abnormality was observed attributable to test item in pups from all treatment groups.
Microscopic examination revealed no abnormality attributable to test item TACOIL at the highest dose tested i.e. 1000 mg/kg body weight.