Registration Dossier

Administrative data

Description of key information

Not acutely toxic

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 June - October
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Test performed by nationally accredited lab with well-defined protocol.
Qualifier:
according to
Guideline:
other: 16 CFR 1500.40
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: NL Industries
- Expiration date of the lot/batch: Lot # 60-8313-01
- Purity test date: N/A

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Not reported
- Stability under test conditions: Assumed to be stable
- Solubility and stability of the test substance in the solvent/vehicle: N/A
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/A

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Used as received
- Preliminary purification step (if any): None
- Final dilution of a dissolved solid, stock liquid or gel: N/A
- Final preparation of a solid: N/A

FORM AS APPLIED IN THE TEST (if different from that of starting material) : 5000 mg/kg

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) : N/A

OTHER SPECIFICS:
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Summit View Farms, Belvidere, New Jersey
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Not reported
- Weight at study initiation: 200-300 g
- Fasting period before study: 18 hr
- Housing: N/A
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: Not reported, To: 1978-08-29
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE: N/A, Substance was used as received

MAXIMUM DOSE VOLUME APPLIED: Not reported

DOSAGE PREPARATION (if unusual): N/A

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Doses:
5000 mg/kg
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 and weighing: Initially and at termination of the study
- Necropsy of survivors performed: Yes
- Other examinations performed: Gross organ pathology at the end of post-dosing observation period.
Statistics:
N/A
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No clinical signs
Body weight:
Normal weight gain
Gross pathology:
No changes in gross pathology

Observation period (N = Normal)

 0 -1 hr 1 -3 hr  3 -6 hr  6 -24 hr  Day 2  Day 3  Day 4  Day 5  Day 6  Day 7 -14  Cumulative
 10N   10N  10N   10N   10N   10N   10N   10N   10N   10N   10N 
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was evaluated for acute oral toxicity according to 16 CFR 1500.40. The test substance was observed to be non-toxic in Sprague-Dawley rats at doses up to 5000 mg/kg.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
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:
1978 June-October
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Test performed by nationally accredited lab with well-defined protocol.
Qualifier:
according to
Guideline:
other: 16 CFR 1500.40
Principles of method if other than guideline:
- Principle of test: To determine the lethality of the test material when applied to the skin of rabbits.
- Short description of test conditions: Test material is applied to either intact or abraded skin of the rabbit, and wrapped in an occluded bandage for 24 hours. Animals were observed for toxicity for 14 days thereafter.
- Parameters analysed / observed: Mortality, overt signs of toxicity, gross organ pathology (necropsy/autopsy), weight changes.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
NL Industries
- Expiration date of the lot/batch:
Lot # 60-8313-01
- Purity test date:
N/A

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Not reported
- Stability under test conditions: Assumed to be stable
- Solubility and stability of the test substance in the solvent/vehicle:
N/A
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
N/A

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
Used as received
- Preliminary purification step (if any):
None
- Final dilution of a dissolved solid, stock liquid or gel:
N/A
- Final preparation of a solid:
N/A

FORM AS APPLIED IN THE TEST (if different from that of starting material)
: N/A

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
: N/A

OTHER SPECIFICS:
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Summit View Farms, Belvidere, New Jersey, USA
- Age at study initiation: Not reported
- Weight at study initiation: 2.3-3 kg
- Housing: Individually housed
- Diet (e.g. ad libitum): Ad libitum Purina Rabbit Chow
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: To: Not reported
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Trunk
- % coverage: Not reported
- Type of wrap if used: non-reactive heavy gauge plastic, covered with opaque wrapping

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported (test material gently wiped off)
- Time after start of exposure: 24 hr

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg
- Concentration (if solution): N/A
- Constant volume or concentration used: yes
- For solids, paste formed: N/A

VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
Duration of exposure:
24 hr
Doses:
1
No. of animals per sex per dose:
5 (2 animals of each sex were abraded, 3 animals of each sex were not abraded)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Initial, termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: irritation (erythema and edema)
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
4 animals exhibited diarrhea during the window of 6 hr - 3 days post-exposure.
Body weight:
No major changes observed
Gross pathology:
No abnormal pathology observed. Irritation was noted at the application sites.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was evaluated under the criteria defined by 16 CFR 1500.40 for acute dermal toxicity in vivo. The test substance was determined to be non-toxic via the dermal route at exposure doses up to 2000 mg.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

The test material was evaluated for in vivo oral and dermal acute toxicity. The test material was observed to be orally non-toxic in doses up to 5000 mg/kg bw and dermally non-toxic in doses up to 2000 mg/kg bw. GHS criteria (Regulation EC No. 1272/2208) for classification as acutely toxic are not met.