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Diss Factsheets

Administrative data

Description of key information

No indication for acute oral or acute dermal toxicity.

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:
July 1998 - September 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
other: rat, Wistar Crl:WI BR (SPF)
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: 35-42 days
- Weight at study initiation:
males: 225.4 g +/- 5.1g; n=5
females: 175.2 g+/- 1.5 g; n=5
- Fasting period before study:
- Housing: Altromin Type S8/15; granulated soft wood bedding
- Diet: (ad libitum): Altromin 1326, pellet standard diet, batch# 140698/1206
- Water (ad libitum): tap water (municipal supply), Makrolon bottles, changed daily

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 50-70 %
- Air changes (per hr): air conditioned
- Photoperiod (hrs dark / hrs light): artificial light was set to give a ccle of 12 hours light and 12 hours dark; the light phase was from 6.30 a.m. - 6.30 p.m

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 6g ad. 30 ml
- Amount of vehicle (if gavage): 6g ad. 30 ml

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight
Doses:
2,000 mg/kg body weight (b.w) using 5 males and 5 females. Individual doses were adjusted according to the body weight on the day of administration.
No. of animals per sex per dose:
2,000 mg/kg body weight (b.w) using 5 males and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and morbidity continuously on the day of administration and once daily thereafter (in the morning). The animals were monitored for general clinical condition continuously on the day of administration and once daily thereafter (in the morning). Body weights were recorded on the day of administration and on days 7 and 14.
- Necropsy of survivors performed: At the end of the observation period all animals were killed by chloroform inhalation. All animals were examined externally. The cranial, thoracic and abdominal cavities were then opened and examined macroscopically.
Statistics:
body weights: Calculation of group mean values and standard deviations.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: On the day of administration of the test article a slight apathy was observed in all animals and a slight squatting position was shortly observed in one male and in two female animals. None of the animals showed furhter alterations of their general state of well-being and behaviour.
Body weight:
The body weight gain was not affected.
Gross pathology:
No macroscopic pathological findings in the animals.

Other findings:
none
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is neither a toxic nor a harmful substance according to this acute oral toxicity study.
Executive summary:

Acute oral toxicity of the test item was tested in male and female Charles River Wistar rats.

The test article was administered at a single dose of 2000 mg/kg body weight by gavage.

Animals were examined for mortality, clinical signs, body weight gain and pathological alterations of organs at the end of a 14-day observation period.

None of the animals died during the course of investigation.

On the day of administration of the test article a slight apathy was observed in all animalsand a slight squatting position was shortly observed in one male and in two female animals.

No pathological findings were observed at necropsy. The body weight gain was not affected.

The LD50 is > 2000 mg/kg body weight .

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
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:
November 1998 - January 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
other: rat, Wistar Crl:WI BR
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: 35-42 days
- mean body weight at study initiation:
males: 291.8 g +/- 9.8 g, n=5
females: 199.8 g +/- 3.1 g; n=5
- Fasting period before study:
- Housing: Altromin Type S8/15, granulated soft wood bedding
- Diet (ad libitum): Altromin 1326, pelleted standard diet, Batch# 150299/1351
- Water (ad libitum): tap water (municipal supply)
- Acclimation period: 13 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22.5°C
- Humidity (%): 45-70%
- Air changes (per hr): air conditioned.
- Photoperiod (hrs dark / hrs light): artificial light was set to give a cycle of 12 our light and 12 hours dark, the light phase was from
6.30 a.m. - 6.30 p.m.
Type of coverage:
occlusive
Vehicle:
water
Remarks:
distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: 6 x 6 cm (trunk)
- Type of wrap if used: covered with aluminium foil (6.5 x 6.5 cm) which was fixed in place with sticking plaster (Lohmann GmbH & Co, Neuwied)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application area was washed with water
- Time after start of exposure: 24 hours after application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.2 g test item/ 100 g body weight. Individual doses were adjusted according to body weight on the day of administration

VEHICLE
- Amount(s) applied (volume or weight with unit): the gauze patch was moistened with distilled water
Duration of exposure:
24 h
Doses:
Dose group: 2000 mg/kg body weight (b.w.)
0.2 g of the test article per 100 g body weight were applied
No. of animals per sex per dose:
5 males per dose
5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and morbidity continuously on the day of administration and once daily thereafter (in the morning). Animals were also observed for erythema and /or oedema at the skin of the application area one hour after patch removal and once daily thereafter (in the morning). Body weights were recorded on the day of administration and on days 7 and 14.
- Necropsy of survivors performed: At the end of the observation all animals were killed by CO2 inhalation. All animal swree examined externally. The cranial, thoracic and abdominal cavities were then opened and examined marcorscopically.
Statistics:
body weights: Calculation of group mean values and standard deviations.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died during the course of investigation.
Male: > 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: > 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Clinical observations: No clinical signs were observed during the cours of investigation.
Body weight:
The body weight gain of the male and female animals was in the renage of th historical control data in the test facility.
Gross pathology:
There were no macroscopic pathological findings in the animals.
Other findings:
Skin of the application area: The skin of the application area was not altered.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is neither a toxic nor a harmful substance according to this acute dermal toxicity study.
Executive summary:

Acute dermal toxicity of the test item was tested in five female and five male Cooles River Wistar rats. The test article was applied at a single dose of 2000 mg/kg bodyweight to a shaved dorsal area of the trunk of the animals and was then covered with a gauze patch which was held in contact with the skin with an occlusive dressing. Exposure was for 24 hours. The area to which it was applied was then washed with water. Animals were examined for mortality, clinical signs, alterations of the application area, body weight gain and pathological alterations of organs at the end of a 14-day observation period. None of the animals died duringthe course of the investigation. Clinical signs, skin alterations on the application area or pathological findings at necropsy were not observed. The body weight gain was not affected.

The dermal LD50 in the rat is > 2000 mg/kg b.w.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity of the test item was tested with rats at a single dose of 2,000 mg/kg body weight by gavage.

None of the animals died during the course of investigation. No pathological findings were observed at necropsy. The body weight gain was not affected. The LD50 oral is > 2000 mg/kg body weight .

Acute dermal toxicity of the test item was tested with Wistar rats. The substance was applied at a single dose of 2,000 mg/kg body weight to a shaved dorsal area of the trunk of the animals. Exposure was for 24 hours. None of the animals died during the course of the investigation. Clinical signs, skin alterations on the application area or pathological findings at necropsy were not observed. The body weight gain was not affected.

The LD50 dermal is > 2000 mg/kg b.w.

There are no data for inhalative toxicity available. Since the vapour pressure of the substance is very low, an inhalative exposure is very unlikely.

Justification for classification or non-classification

The test item needs not to be classified according to directive EC No. 1272/2008 due to these results.