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Description of key information

The oral LD50 in rats was found to be 2300 mg/kg bw after gavage administration. The dermal LD50 in rats was found to be greater than 5000 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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Early study, but reporting the main relevant details, No GLP, short report
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-dates GLP
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: CFY strain
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 100 -116 g
- Fasting period before study: overnight
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 %

MAXIMUM DOSE VOLUME APPLIED: 5,3 to 21,3 ml
Doses:
0 - 1,0 - 1,6 - 2,5 - 4 - 6,4 g /kg
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 2 300 mg/kg bw
Based on:
test mat.
95% CL:
> 2 000 - < 2 700
Mortality:
Death occurred between 1 and 22 hours after treatment. The lowest fatal dose was 1000 mg/kg bw.
Clinical signs:
Signs of reaction to treatment, observed shortly after dosing, included lethargy, pilo-erection, slight diuresis and slight decrease in respiratory rate. Loss of righting was seen in rats treated at 5 and 6.4g/kg. Rats treated at 6.4 g/kg also showed an increase in salivation.
Body weight:
Body weight showed normal development.
Gross pathology:
Autopsy revealed haemorrohage of the stomach and darkening of the liver in deceased anmals only.

Dose (mg/kg)

Mean Body weight (g)

Mortality (x / n)

Time of death (h)

Dosing

1 week

2 weeks

0

104

177

238

0/10

-

1000

115

152

238

1/10

<20

1600

105

165

226

0/10

-

2500

104

168

232

7/10

<20

4000

101

died

-

10/10

<19

6400

104

died

-

10/10

<20

 

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal oral dose (LD 50) and its 95% confidence limits to rats of the test item were calculated to be:
2300 (2000 to 2700) mg/kg bodyweight.
Executive summary:

Male rats of the CFY strain in the weight range 100 to 116 g were starved overnight before treatment with the test item. The test material was prepared as a 30% aqueous solution and administered by oral intubation at varying dosage volumes in the test of 5.3 to 21.3 ml/kg bodyweight. Rats dosed with water alone (21.3 ml/kg) served as controls.

During the observation period of 14 days a record was kept of all mortalities and signs of toxicity. All rats that died were examined macroscopically in arn attempt to identify the target organs, and those animals surviving terminally were similarly examined to detect possible residual damage.

From the mortality data recorded the LD 50 and its 95% confidence limits were calculated by the method of Weil C.S. (1952), Biometrics 8, 249.

RESULTS

Signs of reaction to treatment, observed shortly after dosing, included lethargy, pilo-erection, slight diuresis and slight decrease in respiratory rate. Loss of righting was seen in rats lreated at 5 and 6.4 g/kg. Rats treated at 6.4 g/kg also showed an increase in salivation.

Death occurred between 1 and 22 hours after treatment. Autopsy revealed haemorrohage of the stomach and darkening of the liver.

Recovery of survivors as judged by external appearance and behaviour, was apparently complete within 3 days of treatment. Bodyweight increases were depressed during the first week of the observation period but were normal during the second week compared with controls. Autopsy findings were normal.

CONCLUSION

The acute median lethal oral dose (LD 50) and its 95% confidence limits to rats of the test item were calculated to be:

2300 (2000 to 2700) mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 300 mg/kg bw
Quality of whole database:
reliable with restrictions

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
other:
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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Early study, but reporting the main relevant details, No GLP, short report
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Remarks:
pre-dates GLP
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CFY strain
Sex:
male
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- Type of wrap if used: Al foil + waterproof plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm (40-50°C} dilute soap solution
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume): 6,7 mL/kg
- Concentration: 75 % suspension
- Constant volume or concentration used: yes
- For solids, paste formed: yes
Duration of exposure:
24 h
Doses:
5 000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle
Key result
Sex:
male
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Mortality:
None
Clinical signs:
shortly after dosing slight lethargy. One rat showed slight erythema on the fourth day of treatment only. This rat and another were observed to have small, raised, brown nodules on areas on the treated sites on the day after treatment only
Body weight:
Bodyweight increases were normal compared with the controls
Gross pathology:
Autopsy findings were normal
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal percutaneous dose (LD 50 ) to male rats of the test item was found to be: greater than 5000 mg/kg bodyweight.
Executive summary:

Ten male rats were treated with The test item at a dosage level of 5 g/kg bodyweight.

There were no mortalities. Signs of reaction to treatment, observed shortly after dosing, consisted of slight lethargy only, which persisted for three days. One rat showed slight erythema on the fourth day of treatment only. This rat and another were observed to have small, raised, brown nodules on areas on the treated sites on the day after treatment only. Bodyweight increases were normal compared with the controls. Autopsy findings were normal.

CONCLUSION: The acute median lethal percutaneous dose (LD 50 ) to male rats of gold 4 N was found to be: greater than 5000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
reliable with restrictions

Additional information

Justification for classification or non-classification

No classification

The oral LD50 in rats was found to be 2300mg/kg bw after gavage administration. The dermal LD50 in rats was found to be greater than 5000 mg/kg bw.