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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 December 2016 - 23 December 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
24th February 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Commission Regulation (EC) No. 440/2008, Part B.3, 30 May 2008.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3,5-trimethylcyclohexyl acrylate
EC Number:
289-200-9
EC Name:
3,3,5-trimethylcyclohexyl acrylate
Cas Number:
86178-38-3
Molecular formula:
C12H20O2
IUPAC Name:
3,3,5-trimethylcyclohexyl prop-2-enoate
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France.
- Age/Weight: on the day of treatment, the animals were approximately 8 weeks old. The individual body weight of each individual was within ± 20% of the mean body weight of all the study animals of the same sex (224 g for females and 358 g for males).
- Fasting period before study: yes, during the night before treatment
- Housing: polycarbonate cages
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: 01 December 2016 to 23 December 2016

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 10% of body surface, dorsal site
- Type of wrap if used: hydrophilic gauze pad + adhesive hypoallergenic aerated semi-occlusive dressing + restraining bandage

REMOVAL OF TEST SUBSTANCE
- Removal of dressing: 24h post-exposure
- Washing: at 24h post-exposure, with a moistened cotton pad

TEST MATERIAL
- Amount applied: 2000 mg/kg
- Constant volume: no
Duration of exposure:
24h
Doses:
2000 mg/kg
No. of animals per sex per dose:
five males and five females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on Day 1; then on Days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic).
Statistics:
no

Results and discussion

Effect levels
Key result
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
Mortality:
No unscheduled deaths occurred during the study.

Clinical signs:
On Day 1, ptyalism was noted in 1/5 female and chromodacryorrhea was seen in 1/5 male. No other clinical signs were noted thereafter.

Local reactions at the injection site were recorded and consisted in very slight to well-defined erythema in all animals between Day 2 and Day 6, dryness and/or desquamation in all females and 3/5 males from Day 3 to Day 7, and scabs in 4/5 females and 3/5 males between Day 3 and Day 15.
Body weight:
Body weight of animals was unaffected by the test item treatment.
Gross pathology:
There were no macroscopic findings at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD0 of the test item was higher than 2000 mg/kg in rats.
Executive summary:

The objective of this study was to evaluate the potential toxicity of the test item, following a single dermal application to rats. This study was based on the international guidelines (OECD No. 402 and Council Regulation No. 440/2008 of 30 May 2008, Part B.3) and was performed in compliance with the principles of Good Laboratory Practice.

The test item was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by an aerated hypoallergenic dressing for 24 hours. Each animal was observed at least once a day for mortality and clinical signs for 15 days. From Day 2, any local reactions at the treatment site were also noted. Body weight was recorded on Day 1 and then on Days 8 and 15. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. No tissues were preserved.

No unscheduled deaths occurred during the study. On Day 1, ptyalism was noted in 1/5 female and chromodacryorrhea was seen in 1/5 male. No other clinical signs were noted thereafter in any animals. Local reactions were recorded at the injection site and consisted in very slight to well-defined erythema, dryness and/or desquamation and scabs. 

Body weight of animals was unaffected by the test item treatment. There were no macroscopic findings at necropsy.

In conclusion, the dermal LD0 of the test item was higher than 2000 mg/kg in rats.

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