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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: original study report not available, but secondary source contains sufficient data to assess study as rel. 2

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995
Reference Type:
secondary source
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
861229-15-4
Cas Number:
861229-15-4
IUPAC Name:
861229-15-4
Constituent 2
Reference substance name:
Mecoprop-P 2-ethylhexyl ester
IUPAC Name:
Mecoprop-P 2-ethylhexyl ester
Constituent 3
Reference substance name:
MCPP-P 2-EHE
IUPAC Name:
MCPP-P 2-EHE
Constituent 4
Reference substance name:
R-(+)-2-(4-chloro-2-methylphenoxy)-propionic acid, 2-ethylhexyl ester
IUPAC Name:
R-(+)-2-(4-chloro-2-methylphenoxy)-propionic acid, 2-ethylhexyl ester

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
4 weeks (21 applications)
Frequency of treatment:
5 x 6h/week
Doses / concentrations
Remarks:
Doses / Concentrations:
15, 150, 1000 mg/kg bw
Basis:
nominal per unit body weight
No. of animals per sex per dose:
5
Control animals:
other: yes, solvent control: olive oil DAB 10
Details on study design:
Mecoprop-P 2-EHE was applied 5 days per week for 6 hours to the clipped intact dorsal skin (at least 10 % of the body surface area) of Wistar rats over a period of 4 weeks (21 applications) using a semi occlusive dressing.

Results and discussion

Results of examinations

Details on results:
There were no deaths during the study period. No substance-related differences in food consumption were noted during the study.
Body weight gain in test animals was comparable with that seen in controls.
Incidence and types of clinical signs were not adversely affected by treatment.
No skin irritation was observed.
No substance-related changes were observed in the clinical chemistry and haematology results.
No substance-related significantly different mean absolute or relative organ weights were recorded.
No substance-related microscopic findings were recorded.

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
other: No substance-related findings

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion