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Administrative data

Description of key information

Acute toxicity oral
In a limit test 5 rats/sex received 2000 mg/kg bw of the test substance by gavage. No mortality or clinical signs were observed during the 14 day observation period. The LD50 is > 2000 mg/kg bw.
Studies on the analogues DNNSA and BaDNNSA showed LD50 values of > 2000 mg/kg bw and 1750 mg/kg bw respectively
Acute toxicity inhalation
In view of the use of the substance, no inhalation exposure is expected. In a limited, non GLP study, rats (5/sex) were exposed to the test substance at 7.6 mg/L by inhalation during 1 hour. No mortality or clinical signs were observed during the 14 day observation period. It is therefore concluded that the LC50 is >7.6 mg/L.
Acute toxicity dermal
Rabbits (5/sex) were exposed dermally to 8000 mg/kg of the test substance for 24 hours. No mortality or clinical signs were observed. During the first 6 days animals lost weight. The LD50 is > 8000 mg/kg bw.
Studies on formulations of the analogues DNNSA and BaDNNSA showed LD50 values of > 1000 mg/kg bw (as active ingredient).

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited report, non GLP, no data on weight gain and no macroscopic evaluation. The information allows the derivation of an LD50. The information in the report is limited to the information in the summary.
Qualifier:
according to
Guideline:
other: FHSLA, CFR, Title 21, para. 191.1.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no iiformation on bodyweight gain, clinical signs and macroscopic investigations
Principles of method if other than guideline:
no report on bodyweight (end of study), no details on clinical findings and no macroscopy
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not indicated
- Weight at study initiation: males: 200-218 g; females 203-217 g
- Fasting period before study: 18 hours
- Housing: individually
- Diet/water: no data

ENVIRONMENTAL CONDITIONS: no information available
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

Doses:
2000 mg/kg bw (based on concentration in material)
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations and mortality check daily: weighing at the start of the study
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
NA
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
animals appeared healthy and normal
Body weight:
no data
Gross pathology:
not performed
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test substance is > 2000 mg/kg bw
Executive summary:

In a limit test 5 rats/sex received 2000 mg/kg bw of the test substance by gavage. No mortality or clinical signs were observed during the 14 day observation period. The LD50 is > 2000 mg/kg bw.

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 adverse effect observed
Quality of whole database:
limited non GLP study available; not all parameters investigated, exposure duration only 1 hour.

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited report, non GLP. The information in the report is limited to the information in the summary.
Qualifier:
according to
Guideline:
other: Acute Dermal Toxicity. FHSLA, CFR, Title 21, para. 191.10 and Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the U. 5
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
test partially on animals with abraded skin, no information on body weight gain
Principles of method if other than guideline:
For 3 males and 2 females the skin was abraded before application of the test substance. No report on body weight (end of the study)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not reported
- Weight at study initiation: males: 2.64-3.00 kg; females: 2.54-3.00 kg
- Fasting period before study: NA
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not indicated

ENVIRONMENTAL CONDITIONS: no information provided
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5-6 cm2
- Abrasion: on 5-6 cm2 in 2 males and 3 females
- Type of wrap if used: elastic sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 g/ kg bw
- Concentration (if solution): 40%
Duration of exposure:
24 hours
Doses:
8 g/kg bw (calculation based on concentration)
No. of animals per sex per dose:
5 males + 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations for mortality and clinical signs, frequency of weighing not indicated
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
NA
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none observed
Body weight:
weight loss during day 1-6, thereafter no effects
Gross pathology:
liver necrosis and slightly enlarged right kidney in one male
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test substance is > 8000 mg/kg bw
Executive summary:

Rabbits (5/sex) were exposed dermally to 8000 mg/kg of the test substance for 24 hours. No mortality or clinical signs were observed. During the first 6 days animals lost weight. The LD50 is > 8000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
8 000 mg/kg bw

Additional information

The available studies contain sufficient information to be used for risk assessment and classification and labelling. All tests are performed on a 40% formulation. The effect levels are based on active ingredient, as it is not expected that the diluent has contributed to the effects if any.


Justification for selection of acute toxicity – oral endpoint
Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. No mortality or further adverse effects were observed.

Justification for selection of acute toxicity – dermal endpoint
Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. No mortality was observed.

Justification for classification or non-classification

Based on the available studies and the absence of mortality, the substance does not need to be classified for acute toxicity.