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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
BASF-Test
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:
- Name of test material (as cited in study report): Isophytol G
- Physical state: fluid
- Analytical purity: ca. 90 %
- Impurities (identity and concentrations): not reported

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kißlegg, Allgäu
- Age at study initiation: no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: Traganth
Details on exposure:
Application as 1, 2, 4 and 20 % emulsion in Traganth.
Doses:
100, 200, 400, 1600 µl/kg bw (corresponding to 84, 169, 338, 1350 mg/kg bw, based on a density of 0.844 g/cm³)
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days (1350 and 169 mg/kg bw) and 14 days (338 and 84 mg/kg bw)
- Frequency of observations and weighing: weighing at begin of study, observations daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 169 mg/kg bw
Remarks on result:
other: 200 mm^3/kg bw, converted using a relative density of 0.844
Mortality:
1350 mg/kg bw: 10/10 (1 h)
338 mg/kg bw: males 1/5 (7d), 2/5 (14 d); females 2/5 (7 d)
169 mg/kg bw: males 2/5 (48h) 3/5 (7 d); females 1/5 (48 h)
84 mg/kg bw: males 2/5 (14 d); females 0/5
Clinical signs:
1350 mg/kg bw: directly after injection tachypnea, hollow flanks, apathy
338 mg/kg bw: scampering gait, staggering, tachypnea, hollow flanks, flattened ears, crouching position, ruffled fur, sticky eyes, irregular respiration, symptoms decreasing during observation period; without symptoms after 14 days
169 mg/kg bw: apathy, tachypnea, hollow flanks, ruffled fur, dyspnea, staggering, trembling, crouching position, sticky eyes, symptoms decreasing during observation period; without symptoms after 7 days
84 mg/kg bw: observations identical to 338 mg/kg bw dose group
Staggering, trembling, dyspnea
Gross pathology:
Intrabadominal adhesions and incorporations of substance

Applicant's summary and conclusion