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Diss Factsheets

Administrative data

Description of key information

The test item did not induce acute toxicity after oral and dermal application at 2000 mg/kg.

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:
29-Oct-1996 to 19-Nov-1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD test guideline 401)
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted on 24-Feb-1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd, Wölferstrasse 4, 4414 Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks old (males), 10 weeks old (females)
- Weight at study initiation: 192.9-212.3 g (males), 179.2-188.0 g (females)
- Fasting period before study: overnight fasting prior to the single test item application
- Housing: groups of 5 rats/sex in Makrolon type-4 cages
- Diet: pelleted standard rat maintenance diet (Kliba 343, Kliba Mühlen AG, 4303 Kaiseraugst, Switzerland), ad libitum (with exception of an overnight fasting period prior to dosing; food was provided again 3 hours after dosing)
- Water: tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10-15 changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: 29-Oct-1996 to 19-Nov-1996
Route of administration:
oral: gavage
Vehicle:
other: bidistilled water with a drop of Tween 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: standard vehicle for studies of this type

DOSAGE PREPARATION:
The test article was placed into a glass beaker on a tared Mettler PM 460 balance and the vehicle (bi-distilled water with a drop of TWEEN 80) was added. A weight by volume dilution was prepared using a glass rod and a magnetic stirrer as homogenizers. Homogeneity of the test article in the vehicle was maintained during treatment using the same magnetic stirrer (Janke & Kunkel, 0-79219 Staufen). The preparation was made shortly before dosing.
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: four times during day 1 and once daily thereafter
- Frequency of weighing: on days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
The LOGIT-model could not be used as no deaths occurred.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
other: No clinical signs of toxicity were observed during the study period.
Gross pathology:
No macroscopic findings were observed at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The mean lethal dose of the test item after single oral administration to rats of both sexes, observed over a period of 14 days was found to be greater than 2000 mg/kg.
Executive summary:

In a GLP-compliant acute oral toxicity study according to OECD guideline 401, a group of five male and five female HanIbm:WIST (SPF) rats was treated with test material at 2000 mg/kg by oral gavage. The test article was suspended in vehicle (bi-distilled water and a drop of TWEEN 80) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic findings were observed at necropsy. In conclusion, the mean lethal dose (LD50) of the test item after single oral administration to rats of both sexes, observed over a period of 14 days, was found to exceed 2000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

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:
29-Oct-1996 to 19-Nov-1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD test guideline 402)
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted on 24-Feb-1987
Deviations:
no
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
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd, Wölferstrasse 4, 4414 Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks old (males), 11 weeks old (females)
- Weight at study initiation: 231.1-253.2 g (males), 202.3-224.0 g (females)
- Housing: groups of 5 rats/sex in Makrolon type-4 cages
- Diet: pelleted standard rat maintenance diet (Kliba 343, Kliba Mühlen AG, 4303 Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10-15 changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: 29-Oct-1996 to 19-Nov-1996
Type of coverage:
semiocclusive
Vehicle:
other: bidistilled water with a drop of Tween 80
Details on dermal exposure:
TEST SITE
- Area of exposure: 10 % of total body surface area
- Type of wrap: wrap type not indicated, wrap was fixed with an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 4 mL/kg bw
- Concentration: 500 mg/mL
- Constant volume or concentration used: yes (per kg bw)

VEHICLE
- Amount applied: dose volume of 4 mL/kg bw
Duration of exposure:
24 hours
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: mortality and clinical signs were assessed four times on day 1 and once daily thereafter
- Frequency of weighing: on days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes, including macroscopical examination
Statistics:
The LOGIT-Model could not be used as no deaths occurred.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
other: Neither clinical signs of systemic toxicity nor local effects of the test item on the skin at the application site were observed during the observation period.
Gross pathology:
No macroscopic findings were noted at necropsy.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The mean lethal dose of after single dermal administration to rats of both sexes, observed over a period of 14 days, was found to be greater than 2000 mg/kg body weight.
Executive summary:

In a GLP-compliant dermal acute toxicity study according to OECD guideline 402, a group of five male and five female HanIbm:WIST (SPF) rats was treated with test material at 2000 mg/kg by dermal application. The test article was suspended in bi-distilled water and a drop of TWEEN 80 at a concentration of 0.5 g/ml and administered at a volume of 4 ml/kg. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality and viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study period. Neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period. The body weight of the rats was within the range of physiological variability known for rats of this strain and age. A slight loss of body weight was observed in one female animal during the first and second observation week and in two female animals during the second observation period. No macroscopic organ findings were observed at necropsy. In conclusion, the mean lethal dose of the test item after single dermal administration to rats of both sexes, observed over a period of 14 days, exceeded 2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Oral Toxicity

In a GLP-compliant acute oral toxicity study according to OECD guideline 401, a group of five male and five female HanIbm:WIST (SPF) rats was treated with test material at 2000 mg/kg by oral gavage followed by an observation period of 15 days (RCC, 1996). The test article was suspended in bi-distilled water and a drop of TWEEN 80 at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. No deaths occurred during the study. No clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic findings were observed at necropsy. In conclusion, the mean lethal dose (LD50) of the test item after single oral administration to rats of both sexes was found to exceed 2000 mg/kg.

This result is supported by a second oral toxicity study in Wistar rats, which produced an oral LD50 of greater than 5000 mg/kg (limit dose) in both sexes (MB Research Labs, 1984).

Dermal toxicity

In a GLP-compliant dermal acute toxicity study according to OECD guideline 402, a group of five male and five female HanIbm:WIST (SPF) rats was treated with test material at 2000 mg/kg by dermal application. The test article was suspended in bi-distilled water and a drop of TWEEN 80 at a concentration of 0.5 g/ml and administered at a volume of 4 ml/kg. No deaths occurred during the study period. Neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period. The body weight of the rats was within the range of physiological variability known for rats of this strain and age. A slight loss of body weight was observed in one female animal during the first and second observation week and in two female animals during the second observation period. No macroscopic organ findings were observed at necropsy. In conclusion, the mean lethal dose of the test item after single dermal administration to rats of both sexes, observed over a period of 14 days, exceeded 2000 mg/kg body weight.

This result is supported by a second dermal toxicity study in New Zealand White rabbits, which produced a dermal LD50 of greater than 2000 mg/kg (limit dose) in both sexes (MB Research Labs, 1984).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008,as amended for the seventh time in Regulation (EC) No 2015/1221.