Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-01-29 to 2009-02-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
, 2008
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
, adopted 1987-02-24
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- EC name: Acetic-acid, 2- (ethylamino) -2-oxo, (1R,2S,5R) -5-methyl- 2- (1-methylethyl)- cyclohexyl ester
- Molecular formula: C14H25NO3
- Molecular weight: 255.36g/mol
- Physical state: liquid, colourless, viscous oil
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- SPF Wistar rats of the stock Crl:WI
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld, Germany
- Weight at study initiation: 200 - 228 g; pilot study: 216 g
- Fasting period before study: the rats were not fasted prior dosing.
- Housing: the rats were kept in transparent macrolone cages (type 3-180, floor area 810 sq.cm) with two or three in each cage, males and females separated. The cages were cleaned and the bedding changed at least twice a week. Bedding was "Lignocel-Fasern" from Altromin, 32791 Lage, Germany.
- Diet (ad libitum): complete rodent diet "Altromin 1314" from Altromin, 32791 Lage, Germany.
- Water (ad libitum): domestic quality drinking water wtih hydrochloric acid to pH 2.5.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 to 70 %
- Air changes: 10 times / hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: On the day before the application of the test item the hair was removed from the back and flanks with an electric clipper. On day = the tet item was applied to the prepared skin area of 6x8 cm.
- Type of wrap if used: 4-layer gauze pack, the gauze packs were fixed with Microtape wound around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: mild soap and luke warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw. (sighting study / main study)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw. (sighting study / main study)
No. of animals per sex per dose:
sighting study: one female (2000 mg/kg bw.)
main study: five female / five males (2000 mg/kg bw.)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each rat was observed 1, 3 and 6 hours after the start of dosing and thereafter daily for a period of 14 consecutive days. Body weight was recorded on days 0, 7 and 6 hours after the start of dosing and thereafter daily for a period of 14 consecutive days.
- Necropsy of survivors performed: yes; alle rats were killed by inhalation of CO2 on day 14 and subjected to a gross necropsy examination
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
PILOT STUDY
The animal included in the pilot study appeared apathetic on day 0 after 1 hour, 3 hours and 6 hours. From day 1 to the end of the observation period on day 14 no abnormalities were revealed.
MAIN STUDY
The animals included in the main study showed piloerection on day 0 after 1 hour, 3 hours and 6 hours. From day 1 to the end of the observation period on day 14 no abnormalities were revealed.
Body weight:
PILOT STUDY
The rat had a normal body weight gain during the study period.
MAIN STUDY
The rats had a normal body weight gain during the study period.
Gross pathology:
PILOT STUDY
The post mortem inspection revealed no pathological abnormalities.
MAIN STUDY
The post mortem inspection revealed no pathological abnormalities.
Other findings:
Dermal reactions: there were no signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in the SPF Wistar rats of the stock Crl:Wl was found to be greater than 2000 mg/kg bodyweight.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the dermal route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the dermal route.