Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Documentation insufficient for assessment: reported data are incomplete and partly inconsistent; only limited data about the test substance is given. A non-guideline method was used and the way the dose is calculated for LD50 purposes is questionable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Huntingdon Research Center
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
UDL-738 (aluminosilicate); UDL-739 Model Product (P & G Code)

Test animals

Species:
rat
Strain:
other: Sprague-Dawley derived
Sex:
male

Administration / exposure

Route of administration:
other: intratracheal
Vehicle:
water
Details on exposure:
The test substance was applied once as aqueous suspension at concentrations of:
10, 25, 50, 100, and 300 mg/mL (UDL-738)
3, 10, 25, 50, and 100 mg/mL (UDL-739)
by intratracheal injection of 1 mL.
Doses:
10, 25, 50, 100, and 300 mg/mL (UDL-738)
3, 10, 25, 50, and 100 mg/mL (UDL-739)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The observation period was 14 days.
Statistics:
LD50-values were calculated from the applied doses using a body weight of 250 g, i.e. the doses expressed in mg/kg are by a factor of 4 higher than the doses given as mg/ml per animal.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 12 - 40 mg/kg bw
Mortality:
UDL-738:
Up to and including a dose of 25 mg/mL one animal died per test group (1/10). At a dose of 50 mg/mL 4/10 animals died during the observation period. Mortality decreased at an increased dose of 100 mg/mL (2/10). None of the animals survived at an application dose of 300 mg/L (10/10). Due to the lack of a dose-concentration ship, the LD50 for UDL-738 is not further specified.

UDL-739:
All of the animals dosed with 3 mg/mL survived (10/10); only one (1/10) exhibited incidence of lung gross abnormalities. Weight gain in this group was normal compared to untreated controls. In the group dosed with 10 mg/mL 9/10 animals died within the 14 days. At the higher doses all (10/10) animals died during the experiment.
Body weight:
UDL-739:
All of the animals dosed with 3 mg/mL survived (10/10); only one (1/10) exhibited incidence of lung gross abnormalities. Weight gain in this group was normal compared to untreated controls. In the group dosed with 10 mg/mL 9/10 animals died within the 14 days. At the higher doses all (10/10) animals died during the experiment.
Gross pathology:
UDL-739:
All of the animals dosed with 3 mg/mL survived (10/10); only one (1/10) exhibited incidence of lung gross abnormalities. Weight gain in this group was normal compared to untreated controls. In the group dosed with 10 mg/mL 9/10 animals died within the 14 days. At the higher doses all (10/10) animals died during the experiment.

Applicant's summary and conclusion