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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NSA-100
- Chemical name: Zeolite, silica rich, crystalline, synthetic, non-fibrous
- Framework: orthorhombic
- Related CAS number: 1318-02-1
- Physical state: cream coloured granular solid
- Analytical purity: no data
- Lot/batch No.: 36
- Storage condition of test material: room temperature in the dark
- surface modified with Li

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Kent, UK
- Weight at study initiation: males: 200-214 g, females: 203-218 g
- Fasting period before study: overnight
- Housing: in groups of up to 5
- Diet and water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 48-61
- Air changes (per hr): 15 changes per h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
Suspension
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
- Frequency of observations: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
Range finding study:
There were no deaths. Clinical signs of toxicity noted in females were hunched posture, diarrhoea, red/brown staining around the snout and mouth.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One female was killed in extremis on day 6
Clinical signs:
The female, killed in extremis on day 6, showed hunched posture, lethargy, decreased respiratory rate, tiptoe gait, red/brown staining around the snout and mouth, ataxia, emaciation, ptosis, splayed gait, and body tremor on days 3 to 6 with additional signs of hypothermia, chromodacryorrhoea, dehydration and increased salivation prior to death. No signs of systemic toxcicty were noted in the other animals during the study.
Body weight:
Surviving animals showed an expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were observed at necropsy of animals killed at the end of the study. Haemorrhagic lungs, dark liver, dark kidneys and haemorrhage of the large and small intestines were noted at necropsy of the female killed in extremis on day 6.

Applicant's summary and conclusion