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Administrative data

Description of key information

Oral (OECD 401), rat: LD50: > 2000 mg/kg bw (limit test)

Dermal (OECD 402), rat: LD 50 > 2000 mg/kg bw (limit test)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 4 - December 2, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
GLP compliance:
yes (incl. certificate)
Test type:
up-and-down procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SAGE Labs
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 166-212 g
- Fasting period before study: overnight
- Housing: Singly in suspended stainless steel cages.
- Diet: Envigo Teklad Global 16% Protein Rodent Diet #2016, ad libitum
- Water: ad libitum
- Acclimation period: 5-16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 44-65
- Air changes (per hr): 12-13
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: November 4, 2015 To: December 2, 2015
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30%
- Amount of vehicle (if gavage): 70%

MAXIMUM DOSE VOLUME APPLIED: 1.4 mL

DOSAGE PREPARATION: Test substance was ground and mixed with water to form a 30% (w/w) solution.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for the first 30 minutes post dosing, and for several hours thereafter. After the first day, animals were observed daily. Body weights were assessed prior to dosing and on Day 6 or 7, and Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Preliminary study:
One animal was dosed initially. As the animal survived, another four were also dosed.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived the study.
Clinical signs:
No signs of adverse effects were noted at any observation.
Body weight:
All animals gained weight as expected during the study.
Gross pathology:
No signs of gross toxicity were noted.
Other findings:
- Histopathology: No gross abnormalities were noted.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The acute oral LD50 is > 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the test substance Sucrose Palmitate Stearate MDT Grade was tested in rats. 5 female rats were exposed to a single dose of 2000 mg/kg bw of test substance by oral gavage.

All animals survived the exposure. There were no signs of adverse effects in the animals for 14 days after exposure. The acute oral LD50 is > 2000 mg/kg bw. The test substance is not toxic via the oral route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfill the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 29 - November 12, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SAGE Labs
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 267-286 g males, 179-195 g females
- Housing: Singly in suspended stainless steel cages.
- Diet: Envigo Teklad Global 16% Protein Rodent Diet #2016, ad libitum
- Water: Filtered tap water, ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 40-61
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: October 29, 2015 To: November 12, 2015
Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 2 x 3 inches (approx. 5 x 7.5 cm)
- % coverage: 10% of body area
- Type of wrap if used: Gauze pad covered by Durapore tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Washed with 3% soap solution followed by tap water.
- Time after start of exposure: 24 hrs.

TEST MATERIAL
- Treatment of test material prior to testing: Test substance was ground and passed through 425 micron sieve.
- Concentration (if solution): 60% (w/w) test substance/water
- Constant volume or concentration used: yes
- For solids, paste formed: yes



Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for several hours after dosing, and then at least daily thereafter. Weighing was performed on Day 0, Day 7, and Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Statistics:
Not used.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was seen during the study.
Clinical signs:
All animals appeared active and healthy during the study.
Body weight:
All animals gained weight as expected during the study.
Gross pathology:
No abnormalities were noted during necropsy.
Other findings:
- Histopathology: No abnormalities were noted.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The acute dermal LD50 is > 2000 mg/kg bw. The test substance is not toxic by the dermal route.
Executive summary:

5 male and 5 female rats were exposed to a dose of 2000 mg/kg bw of the test substance Sucrose Palmitate Stearate MDT Grade dermally for 24 hrs under occlusive conditions. The animals were observed for 14 days after the end of exposure. No mortality was observed in the test animals, nor any other adverse effects. The acute dermal LD50 is > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfill the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Oral

The acute oral toxicity of the test substance was assessed in a study with rats according to OECD Guideline 425 and in compliance with GLP (Lowe, 2016). The test substance was applied via gavage as 30% dilution in water. A dose of 2000 mg/kg bw (limit test) test substance was administered to one female (first step). As this animal survived, another four animals were dosed with 2000 mg/kg bw. Animals were observed for mortality and general clinical condition 30 min after administration up to several hours and daily for 14 days thereafter. Body weights were recorded before administration and on Days 6 or 7 and 14. Macroscopic examination and histopathology was performed in the end of the observation period at terminal sacrifice. None of the animals died and no clinical symptoms were observed during the study. The body weight gain was not affected by the administration of the test substance. No abnormalities were noted at necropsy. Based on the results of this study, the oral LD50 value was determined to be > 2000 mg/kg bw in rats.

 

In a supporting study, the acute oral toxicity was assessed in a study equivalent to OECD Guideline 401 with limited documentation (Bouffechoux, 1995). A single oral dose of 2000 mg/kg bw (limit test) was given to 5 female Swiss mice. Animals were observed for mortality, body weight, general clinical signs and behavior for 14 days. None of the animals died and no clinical symptoms or changes in behavior were observed during the study. The body weight gain was not affected by the administration of the test substance. Based on the results of this study, the oral LD50 was determined to be > 2000 mg/kg bw in mice. This study was not taken into account for hazard assessment.

 

Dermal

The acute dermal toxicity of the test substance was assessed in a limit test performed in 5 male and 5 female Wistar rats according to OECD Guideline 402 and in compliance with GLP (Lowe, 2015). A single dose of 2000 mg/kg bw of the test substance was applied to the clipped skin of rats under occlusive conditions for 24 hours. Animals were observed for mortality and general clinical condition for several hours after dosing and daily for 14 days thereafter. Body weights were recorded on Day 0, 7 and 14. Macroscopic examination and histopathology was performed in the end of the observation period at terminal sacrifice. None of the animals died and no clinical symptoms were observed during the study. The body weight gain was not affected by the administration of the test substance. No abnormalities were noted at necropsy. Based on the results of this study, the dermal LD50 value was determined to be > 2000 mg/kg bw in rats.

 

Justification for classification or non-classification

The available data on acute oral and acute dermal toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.