Ashes (residues), plant

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

Based on the available information, there is no evidence for reproduction toxicity for substance Ashes (residues), plant and therefore, based on Annex X, section 8.7 column 2 of the REACH and for animal welfare reasons, conduct of Extended One-Generation Reproductive Toxicity Study (OECD TG 443) is not scientifically necessary and, considering concerns regarding the use of vertebrate animals for experimental purposes, unjustified.

Effects on developmental toxicity

Description of key information

The prenatal developmental toxicity study according to OECD TG 414 by oral administration in rats is available for the substance The product from the burning of a combination of carbonaceous materials (EC: 931-597-4) and was used for the read-across. No mortality occurred during the study. No test item related body weight effects were observed in any of the dose groups. No changes in the food consumption in any of the dose groups was observed during the treatment period. No test item related macroscopic and microscopic findings were present at necropsy in the surviving animals. There were no statistically significant changes in the concentration of the T3, T4 and TSH level between the Control and the Dose groups. There were no statistical differences in the organ weights between the control and the Dose groups. There were no statistically significant differences in the intra-uterine parameters in the test item treated animals when compared to the controls. There was no toxicologically significant difference in the foetal weights of either sex of foetuses, sex distribution or on anogenital distance between the control and treatment groups. There were no adverse test item related effects on external, visceral or skeletal development of foetuses in the study. Foetal malformations observed in the study were all considered to be incidental. They showed no dose dependency and thus were not regarded as a test item related effect. In conclusion, The product from the burning of a combination
of carbonaceous materials, when administered daily by oral gavage to pregnant Hannover Wistar rats from gestation days GD6 to GD19 at 1000 mg/kg bw/day induced no maternal systemic toxicity and no effect on body weight or growth. No effect on the embryotoxicity and foetotoxicity was observed (number of foetuses with retarded body weight and malformations) in the study based on overall development. NOAELmaternal toxicity of 1000 mg/kg bw/day was derived based on no maternal systemic effects at 1000 mg/kg bw/day. NOAELembryotoxicity of 1000 mg/kg bw/day was derived based on the lack of any test-item related intra-uterine effect in any treatment group. NOAELfoetotoxicity of 1000 mg/kg bw/day was derived based on no effect on runts at 1000 mg/kg bw/day. NOAELteratogenecity of 1000 mg/kg bw/day was derived based on the lack of treatment related malformations in any dose group. Based on the results from the prenatal developmental toxicity study no classification for reproductive toxicity is warranted.

Link to relevant study records

Reference

Endpoint:

developmental toxicity

Remarks:

Pre-natal developmental toxicity study (OECD TG 414), on one species

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

The data for Ashes (residues), plant (EC: 297-049-5) for developmental toxicity was predicted using read across approach, based upon the similarity of substances (composition), test results (matching), similar classification and the same production technology and consecutive usage, from source chemical The product from the burning of a combination of carbonaceous materials (EC: 931-597-4) to target chemical Ashes (residues), plant (EC: 297-049-5)
For detailed information, please, see the attached document for justification

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Basis for effect level:

other: Parameters according to OECD Test Guideline 414

Key result

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: Parameters according to OECD Test Guideline 414

Developmental effects observed:

no

Conclusions:

The data for developmental and reproductive toxicity of source chemical (The product from the burning of a combination of carbonaceous materials) was used to fill the data gap of these endpoints for target chemical (Ashes (residues), plant) based upon the similarity of substances (composition), test results (matching), similar classification and the same production technology and consecutive usage.

The following no-observed-adverse-effect (NOAEL) levels were derived:
NOAELmaternal toxicity: 1000 mg/kg bw/day
Based on no maternal systemic effects at 1000 mg/kg bw/day.
NOAELembryotoxicity: 1000 mg/kg bw/day
Based on the lack of any test-item related intra-uterine effect in any treatment group.
NOAELfoetotoxicity: 1000 mg/kg bw/day
Based on no effect on runts at 1000 mg/kg bw/day.
NOAELteratogenecity: 1000 mg/kg bw/day
Based on the lack of treatment related malformations in any dose group.

Executive summary:

The target and source chemicals with very similar or identical usage and composition/structural similarity, which results in a likelihood that the substances have similar physicochemical, toxicological and ecotoxicological properties.

Both, target and source chemical are UVCB substances which are produced by combustion. The main components in these substances are presented as oxides of various elements such an aluminium, calcium, iron, magnesium, phosphorous, potassium, sodium and silicon.

The available physical-chemical, ecotoxicological and toxicological data for target and source chemical were determined mainly with identical or similar results. The data for developmental and reproductive toxicity of source chemical (The product from the burning of a combination of carbonaceous materials) was used to fill the data gap of these endpoints for target chemical (Ashes (residues), plant) based upon the similarity of substances (composition), test results (matching), similar classification and the same production technology and consecutive usage.

Justification for classification or non-classification

Based on the results from the prenatal developmental toxicity study and no adverse effects on reproductive organs or tissues and no other concerns in relation with reproductive toxicity observed in repeated dose 90-day oral toxicity study in rats no classification for reproductive toxicity is warranted.