Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
other: Huntingdon Research Center
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
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