D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 November 2013 to 03 December 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in accordance with recognised guideline

Justification for type of information:

With regard to why some higher tier testing was conducted and included in this dossier without prior to submission of a testing proposal to EU:  global chemical companies who manufacture and/or place substances on the global market are obligated to meet the relevant chemical control laws in each jurisdiction that they do business. For this EC number 941-129-0, additional testing was required in order to meet global registration requirements outside of the EU.  The requirements of Article 22 of REACH place a responsibility on the registrant to update their registration with relevant new information.  These additional studies required for non-EU global registration purposes were deemed as relevant information and hence they were included in the EU REACH dossier. 

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates

EC Number:

941-129-0

Cas Number:

1407974-32-6

Molecular formula:

C15H28O7 - C25H46O7

IUPAC Name:

D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates

Test material form:

liquid: viscous

Details on test material:

- Substance type: UVCB
- Physical state: Viscous liquid
- Analytical purity: 100% as UVCB
- Storage condition of test material: Room temperature in the dark

Test animals

Species:

rat

Strain:

other: RccHan WIST(SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories, B.V. Horst, Netherlands
- Age at study initiation: 8 to 12 Weeks
- Weight at study initiation: Males 242.6 to 281.7g, Females 208.79 to 210.74g
- Fasting period before study: None
- Housing: Makrolon Type 3 cages furnished with woodflakes.
- Diet (e.g. ad libitum): Teklad Rat-Mouse Rodent Diet. ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): >30 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours continuous light/dark cycle


IN-LIFE DATES: 12 November 2013 to 03 December 2013

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: ca. 10%
- Type of wrap if used: self adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water, dried with paper towels.
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 500 mg/ml, 4 ml/kg body weight
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

Single dose level of 2000 mg/kg bodywight

No. of animals per sex per dose:

5m, 5f, dosed at 2000 mg/kg bw

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were observed for deaths or overt signs of toxicity ½, 1, 2, 3 and 5 hours after dosing and subsequently twice daily for 15 days. Animals were weighed on days 1, 8 and 15
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, dermal reaction

Statistics:

No statistical analysis was performed.

Results and discussion

Preliminary study:

not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No intercurrent deaths occured during the course of the study.

Clinical signs:

other: Scratching was observed on the back of one female (animal No. 7) during the first two days after removal of dressing.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of the test substance after single dermal application to rats of both sexes, observed over a period of 14 days, is greater than 2000 mg/kg body weight.

Executive summary:

Test Guidance

OECD Guideline 404 and EC Method B3

Method and materials

Five male and five female RccHan:WIST (SPF) rats were treated with the test substance at the limit dose of 2000 mg/kg by dermal application. The test item was formulated in PEG 300 at a concentration of 0.5 g/mL and administered at a dose volume of 4 mL/kg. The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, viability, clinical signs and local dermal signs were recorded. All animals were examined for clinical signs before treatment, within the first 30 minutesand approximately 1, 2, 3 and 5 hours after treatment on test day 1 and once daily during test days 2 - 15. Local dermal signs were noted once daily from test day 2 to 15. Mortality/viability was recorded before treatment, within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during test days 2 - 15. Body weights were recorded on test day 1 (prior to administration) and on test days 8 and 15. All animals were necropsied and macroscopically examined.

Results

No intercurrent deaths occurred during the course of the study. Scratching was observed on the back of one female during the first two days after removal of dressing. No local dermal signs were observed throughout the entire observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.

Conclusion

The median lethal dose of the test substance after single dermal application to rats of both sexes, observed over a period of 14 days, is: LD50 (rat) greater than 2000 mg/kg body weight.