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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Remarks:
other: CLP calculation method
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
other: software
Title:
Unnamed
Year:
2018

Materials and methods

Principles of method if other than guideline:
Toxicity to reproduction of UVCB substance was determined by classifying based on Mixture rules from EU CLP (tier 2=summation of classified components to derive Hazard class)
GLP compliance:
no
Remarks:
equivalent quality assurance

Test material

Constituent 1
Reference substance name:
Indium, cake
EC Number:
273-794-1
EC Name:
Indium, cake
Cas Number:
69029-48-7
IUPAC Name:
Insoluble indium-containing residue after precipitation of indium bearing solutions

Test animals

Species:
other: standard species relevant to acute toxicity classification

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
not examined

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not examined

Effect levels (P0)

Remarks on result:
not measured/tested
Remarks:
prediction

Target system / organ toxicity (P0)

Critical effects observed:
not specified

Results: P1 (second parental generation)

General toxicity (P1)

Clinical signs:
not examined

Reproductive function / performance (P1)

Reproductive function: oestrous cycle:
not examined

Effect levels (P1)

Remarks on result:
not measured/tested
Remarks:
prediction

Target system / organ toxicity (P1)

Critical effects observed:
not specified

Results: F1 generation

General toxicity (F1)

Clinical signs:
not examined

Developmental neurotoxicity (F1)

Behaviour (functional findings):
not examined

Developmental immunotoxicity (F1)

Developmental immunotoxicity:
not examined

Effect levels (F1)

Remarks on result:
not measured/tested
Remarks:
prediction

Target system / organ toxicity (F1)

Critical effects observed:
not specified

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

The calculated classification via additivity method resulted in a "reproductive toxicity cat 1A" classification for the UVCB substance (toxicity of all metal constituents are known from 9th ATP CLP + all assessed metals). The result is mainly driven by lead compounds.

Applicant's summary and conclusion

Conclusions:
Good quality study that can be used to derive classification of the UVCB substance and predict hazard. Note toxicities of constituents/species as of 9th ATP CLP + assessed metals
Executive summary:

The study provided a conservative estimate of the reproductive toxicity: classification of both typical and boundary samples is reprotoxic cat 1A