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Diss Factsheets

Administrative data

Description of key information

Oral (EU Method, B.1), rat: LD50 > 2000 mg/kg bw

Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw

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:
05 Jun - 29 Oct 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
adopted in 1992
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
adopted in 2008
Deviations:
yes
Remarks:
environmental conditions for the animal housing: temperature was 24 ± 2 °C instead of 22 ± 3 °C
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Crj:CD (SD) IGS
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Japan, Inc., Hino Breeding Center, Shiga, Japan
- Age at study initiation: 6 weeks
- Weight at study initiation: 202 - 227 g (males) and 156 - 174 g (females)
- Fasting period before study: 20 h before dosing and 4 h after dosing
- Housing: 2 - 3 animals of the same sex were placed in a suspended aluminium cage with wire-mesh floor (22.4 cm x 41.9 cm x 20.0 cm height)
- Diet: CRF-1 laboratory animal chows, sterilized by G0Co at 30 kGy, pellet type (Oriental Yeast Co., Ltd., Tokyo, Japan), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 9 days
- Microbiological status when known : SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): more than 10
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % aqueous solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Observation of clinical signs and mortality was carried out at 10 and 30 min, 1, 2 and 4 h after administration and once daily for 2 weeks thereafter.
- Frequency of weighing: Each animal was weighed on Days 0, 7 and 14 during the observation period.
- Necropsy of survivors performed: Yes, at the end of observation period, all animals were exsanguinated from the abdominal aorta under pentobarbital anesthesia, and were necropsied for gross pathological examination.
Statistics:
Analysis of variance in one way classifications was performed for mean body weight and mean body weight gain. With regard to the parameters in which a significant difference was found at the 5% level, the least significant difference (LSD) method was used as a test for significant difference compared with the control group.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Gross pathology:
Retention of white substance in the urinary bladder was observed in 2/5 males of the control group and in 1/5 males at 2000 mg/kg bw. Retention of fluid in the uterine horn were found in 2/5 females at 2000 mg/kg bw. The findings were considered to be not treatment-related.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study (RL1), and is thus sufficient to fulfil 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:
20 Feb - 13 Mar 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1987
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
Version / remarks:
adopted in 2017
Deviations:
yes
Remarks:
no stepwise dosing approach, 5 animals/sex used
GLP compliance:
yes (incl. QA statement)
Remarks:
The Swiss GLP Monitoring Authorities, Bern, Switzerland
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
HanBrl: WIST
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding, Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks (males) and 12 weeks (females)
- Weight at dosing: 249.3 - 290.2 g (males) and 190.6 - 207.8 g (females)
- Housing: During acclimatization in groups of 5/sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation.
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintainance diet (Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum
- Water: Community tap water, ad libitum
- Acclimation period: 20 - 26 Feb 2003
- Microbiological status when known : SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70 (values > 70% during cleaning process possible)
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped skin on the back of the animals
- % coverage: approximately 10%
- Type of wrap if used: The test material was held in contact with a semi-occlusive dressing. The dressing was wrapped around the abdomend and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 4 mL/kg bw
- Concentration: 0.5 g/mL
- Constant volume or concentration used: yes

VEHICLE
- Amount applied: 4 mL/kg bw
Duration of exposure:
24 h
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: The animals were observed daily during acclimatisation and twice daily during Days 1-5 for mortality and viabilitx. Clinical signs of toxicity were recorded daily during acclimatisation and at approx. 1, 2, 3 and 5 h after administration in test Day 1. Thereafter, the animals were observed once daily during Days 2-15.
- Frequency of weighing: On test Days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: Yes. All animals were killed at the end of the observation period by an intraperitoneal injection of Vetanarcol at a dose of at least 2.0 mL/kg body weight (equivalent to at least 324 mg sodium pentobarbitone/kg body weight) and underwent macroscopic examinations. No organs or tissues were retained.
Statistics:
No statistical analysis was used.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No systemic or local signs of toxicity were observed during the study period.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study (RL1), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No. 1907/2006.

Additional information

Acute oral toxicity:

Sumilizer GP was tested for acute oral toxicity according to EU Method, B.1 (standard acute method) and in compliance with GLP. The test item was dissolved in 0.5% aqueous carboxymethyl cellulose and applied by oral gavage to male and female Crj:CD (SD) IGS rats. Each 5 male and 5 female rats received a single dose of 2000 mg/kg bw or the corresponding vehicle. After administration, the animals were observed for a time period of 14 days to assess general health, body weight gain and mortality. At the end of the observation period and in case of mortality, gross necropsy was performed on all surviving and descendent animals.

No mortality was observed during the study period and there were no clinical signs of toxicity noted for any animal. In addition, all animals gained body weight as expected. At gross necropsy, retention of white substance in the urinary bladder was observed in 2/5 males of the control group and in 1/5 males at 2000 mg/kg bw. Retention of fluid in the uterine horn were found in 2/5 females at 2000 mg/kg bw. The findings were not attributed to treatment and considered as toxicologically not relevant.

Under the conditions of the test, the acute oral lethal dose (LD50) was > 2000 mg/kg bw for male and female rats.

 

Acute dermal toxicity:

Sumilizer GP was tested for acute dermal toxicity in male and female Wistar rats according to OECD guideline 402 and in compliance with GLP. The test item was dissolved in polyethylene glycol (PEG 300) and 4 mL/kg bw were applied to the clipped skin on the back of the animals. Each 5 animals per sex were exposed to the test item for 24 h to a limit dose of 2000 mg/kg bw under semi-occlusive conditions. After patch removal, the skin was flushed with lukewarm tap water and dried with disposable paper towels. During a 14-day observation period, all animals were observed for general health, body weight changes and mortalities. At study termination, all animals underwent necropsy.

No mortality occurred and no signs of systemic or local toxicity were observed throughout the whole study period. In addition, there was no treatment-related impairment of body weight development. Gross necropsy at study termination revealed no substance-related findings.

Under the tested conditions, the acute dermal LD50 in male and female rats was > 2000 mg/kg bw.

Justification for classification or non-classification

The available data on acute oral toxicity and acute dermal toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.