Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: 28 day screening study
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Study period:
28 day
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Based on absence of reported effects to reproductive organs in oral sub-acute study over 28 days.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: Information from SNIF file. Permission to refer granted from ECHA
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Method B7
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0,10,50,500 mg/kg bw/day
Basis:
nominal conc.
No. of animals per sex per dose:
10 per sex per dose
Control animals:
yes

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
> 50 mg/kg bw/day (nominal)
Remarks on result:
other: Generation not specified (migrated information)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In view of no data being presented in the 28 day oral toxicity study that indicated effects to the reproeductive organs and there being no similarity with known reproductive toxins, it is not conisdered justified to perform a new animal test.
Executive summary:

There is predicted to be low exposure to workers under controlled workplace conditions and no exposure to the general public. EUSES modelling with ConsExpo suggests a low risk of accumulation in foodr and drinking water.

The absence of relevant systemic effects in the 28 day oral study and the low exposure would suggest it is inappropariate to perform further animal studies to meet this end point. If the tonnage exceeds 100 t per annum or if use types change that could lead to increased human exposure, specific reproductive toxicity testing may be necessary.