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Administrative data

Description of key information

In the CIBA-Geigy (No. 811427, 1981) acute oral toxicity study conducted according to the OECD-Guideline 401, the oral LD50, was determined to be > 5000 mg/kg body weight. In the CIBA-Geigy (No. 840389, 1984) acute dermal toxicity study conducted according to the OECD-Guideline 402 the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw in rats (no mortality).

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 13, 1981 - December 2, 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-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:
rat
Strain:
other: Tif: RAIf (SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Tierfarm, CH-4332 Sisseln
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 163 - 190 g
- Fasting period before study: over night, prior to dosing
- Housing: groups of 5 in macrolon cages type 3 with standardized soft wood bedding
- Diet: rat food, Nafag No. 890
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
5000 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 or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations: daily
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
Statistics:
For the body weights, the group means and their standard deviation were calculated.
The LD50 including the 95 % confidence limit were computed by the logit method.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1 female animal died 2 days post application.
Mortality:
1 female animal died 2 days post application.
Clinical signs:
other: Dyspnoea, ruffled fur and curved body position were observed directly after application and lasted up to day 7 post application. For several hours or days, respectivley, sedation and diarrhoea was also observed. All clinical signs were reversible within t
Gross pathology:
No compound related gross organ changes were observed.

Table 1: Body Weights (g) and Standard Deviation

Dose (mg/kg bw)

Day 1

Day 7

Day 14

 

Males

5000

182 (5.8)

206 (9.3)

250 (15.7)

 

Females

5000

171 (5.2)

178 (6.9)

202 ( 5.5)
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Upon an acute oral administration and a 14 day post-treatment observation period, an LD50 of > 5000 mg/kg bw was determined in the rat.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 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:
May 15, 1984 - May 29, 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP-like quality control
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Rat, Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 177-239 g
- Housing: individually in Macrolon cages type 2 with standardized soft wood bedding
- Diet (ad libitum): Rat food, NAFAG No. 890
- Water (ad libitum): drinking water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: skin of the back (Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.)
- Type of wrap if used: gauze lined dressing, which was fastened around the trunk with an adhesive elastic bandage.

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg bw
Duration of exposure:
24 hours
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 or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations: mortality (daily, a.m. and p.m. on working days, a.m. on weekends), signs and symptoms (daily)
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed.
Mortality:
No mortality was observed.
Clinical signs:
other: Dyspnoea, exophthalmus, ruffled fur, curved and ventral body position were seen, defined as common symptoms in this type of experiment. In addition, a slight sedation and diarrhea was observed. A localised erythema was noted on the site of application. Th
Gross pathology:
No gross lesions were found at necropsy.

Table 1:Body Weights (g) and Standard Deviation

Dose (mg/kg bw)

Day 1

Day 7

Day 14

 

Males

2000

212 (16.0)

245 (22.1)

288 (28.3)

 

Females

2000

197 (18.3)

200 (17.5)

214 (16.6)
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Upon an acute dermal administration and a 14 day post-treatment observation period, an LD50 of > 2000 mg/kg bw was determined in the rat.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity

In the available CIBA-Geigy (No. 811427, 1981) study the acute toxic effects of the test substance was investigated after a single oral administration to rats. The investigations were performed in accordance with the OECD-Guideline 401 (Limit test). The test substance was administered once orally via gavage to 5 male and 5 female RAIf rats Tif:(SPF) suspended in polyethylene glycol (dose volume was 10 ml/kg bw) at a dose of 5000 mg/kg bw. Body weight and body weight gains were determined before administration, 7 and 14 days after the administration (p.a.); clinical observations were performed at least once per day during the 14 days observation period and all animals were sacrificed and necropsied 14 days p.a.. Dyspnoea, ruffled fur and curved body position were observed directly after treatment and lasted up to day 7 p.a.. For several hours or days, respectivley, sedation and diarrhoea was also observed. All clinical signs were reversible within the observation period. The animals gained body weight as expected.1 female animal died 2 days post application. No compound related gross organ changes were observed. The oral LD50, was determined to be > 5000 mg/kg body weight.

 

Acute inhalation toxicity

No data available.

 

Acute dermal toxicity

In the available CIBA-Geigy (No. 840389, 1984) acute dermal toxicity study conducted according to the OECD Guideline 402 (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the unchanged test substance (skin of the back, covered by semi occlusive dressing) for 24 hours. The application area corresponds to at least 10% of body surface area. The animals were observed for 14 days.

Dyspnoea, exophthalmus, ruffled fur, curved and ventral body position were seen, being common symptoms in this type of experiment. In addition, a slight sedation and diarrhea was observed. A localised erythema was noted on the site of application. The animals recovered within 11 days. The animals gained body weight as expected. No gross lesions were found at necropsy. Since no mortality occurred, the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw in rats.


Justification for selection of acute toxicity – oral endpoint
GLP-Guideline study

Justification for selection of acute toxicity – dermal endpoint
Guideline study performed under GLP-like quality coltrol.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for acute toxicity is not warranted under Directive 67/548/EEC.

 

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

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No.1272/2008.