Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Peer-reviewed assessment report (attached in section 13)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Version / remarks:
US EPA FIFRA Guideline §81-2
Deviations:
yes
Remarks:
Purity of the test compound was not determined by the laboratory prior to conduct of the test.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
GLP compliance:
yes
Remarks:
self-certified to US EPA regulations at 40 CFR Parts 160 and 792
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Chemical name
IUPAC: 6-ethoxy-2,2,4-trimethyl-1,2-dihydroquinoline
CAS: 6-ethoxy-1,2-dihydro-2,2,4-trimethylquinoline

Test animals

Species:
rat
Strain:
other: Crl:CD®BR albino rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc. Portage MI USA

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped, intact skin

REMOVAL OF TEST SUBSTANCE yes
Duration of exposure:
24h
Doses:
2000 mg/kg bw / 1.98 mL/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal findings

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
There were no deaths up to the limit dose of 2000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
There were no deaths up to the limit dose of 2000 mg/kg bw
Mortality:
There were no deaths up to the limit dose of 2000 mg/kg bw.
Clinical signs:
There were no test material-related clinical observations up to the limit dose of 2000 mg/kg bw.
Body weight:
There were no body weight changes up to the limit dose of 2000 mg/kg bw.
Gross pathology:
There were no gross necropsy findings up to the limit dose of 2000 mg/kg bw.
Other findings:
The test material induced very slight to slight erythema on eight rats. Ten sites had desquamation. There was no edema or other dermal findings. With the exception of desquamation noted for two females, all dermal irritation completely subsided by day 12 or earlier.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
As information was provided via a peer-reviewed assessment report, it can be considered as sufficiently reliable to assess the acute dermal toxicity of ethoxyquin towards rats. Ethoxyquin was found to be of a low order of acute toxicity following exposure of rats via the dermal route. On the basis of this study and in accordance with Annex VI of Commission Directive 2001/59/EC ethoxyquin shall not be classified with respect to acute dermal toxicity. The same applies to Regulation 1272/2008, as the LD50 is clearly above the limit dose for classification of 2000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study (US EPA FIFRA Guideline §81-2, which is equivalent to OECD 402), groups of Crl:CD®BR albino rats (5/sex/dose) were dermally exposed to neat ethoxyquin for 24hours at a limit dose of 2000 mg/kg bw.  Animals then were observed for 14 days.

Dermal LD50> 2000 mg/kg bw

Dermal LD0≥ 2000 mg/kg bw

There were no deaths, test material-related clinical observations, body weight changes, or gross necropsy findings in this limit test. The test material induced very slight to slight erythema on eight rats.

Ethoxyquinis of low Toxicity and does not need to be classified according to Regulation 1272/2008.