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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: 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: see 'Remark'
Remarks:
The study was conducted according to the OECD guideline 423 and in compliance with GLP. The substance used for read across (Triphenyl-(4-vinyl)cyclohexyl-methylphospohniumiodid, D 6) is structurally very similar to the registered substance Triphenyl-(4-propenyl)cyclohexyl-methylphosphoniumiodid (E 6). The only difference concerns the length of side chain in para position of the hexylring being a vinyl group for D 6 and a propenyl group for E 6. Therefore a read-across from D 6 to E 6 is considered reliable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
1171067-76-1
IUPAC Name:
1171067-76-1

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation:approximately 5 weeks at start of acclimatisation
- Weight at study initiation: 205.3 g +/- 16.0 g
- Fasting period before study: the night before administration and 3 hours after administration
- Housing:up to 3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5-23°C
- Humidity (%): 30-50%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% (m/v) solution of Tylose MH 1000
Details on oral exposure:
Route of administration: orally, by gavage; using a metal catheter and disposable plastic syringes
Rationale: The acute toxicity is to determine at first by the oral administration.
Form ofadministration: The test item was suspended after crushing with a pestle and mortar to a fine dust shortly before administration in a
0.5 % (m/v) solution of Tylose MH 1000 in deionised water by mixing and continuously mixed by a stirrer during the administration. The
homogeneity was proved visually.
Dose group 2000 mg/kg b.w.: 3 g test item filled up to 15 ml using Tylose solution
Dose group 300 mg/kg b.w.: 0.45 g test item filled up to 15 ml using Tylosesolution
Volume of administration: 1ml / 100 g body weight. Individual doses were adjusted according to the recorded body weight.
Single administration.
Doses:
Dose groups: 2000 mg/kg body weight (b.w.), 300 mg/kg b.w.
No. of animals per sex per dose:
Dose group 2000 mg/kg b.w.: 3 animals
Dose group 300 mg/kg b.w.: 6 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at 1, 2, 3, 6 and 8 h after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
All animals were examined externally. The cranial, thoracic and abdominal cavities were then
opened and examined macroscopically.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All three animals of the dose group 2000 mg/kg b.w. died within the second hour after administration.
All animals of the dose group 300 mg /kg b.w. survived the 14 day observation period.
Clinical signs:
The animals responded very quickly to the administration of the test item. The animals of the dose group 2000 mg/kg b.w. showed apathy, coma,
abdominal position and gasping respiration one hour after administration of the test item. These animals died in the course of the following hour.
The animals of the dose group 300 mg/kg b.w. showed only briefly a squatting position two to three hours after administration of the test item. Not
any alterations of the general state of well-being were observed in these animals from six hours after administration.
Body weight:
The body weight gain of the animals of the dose group 300 mg/kg b.w. was not affected by the administration of the test item.
Gross pathology:
In the dead animals of the dose group 2000 mg/kg b.w. a white mushy stomach content ( caused by the test item suspension) and partly severe
atelectatic areas in the lungs were observed. No substance dependent pathological findings were observed in the animals of the dose group
300 mg/kg b.w. The diaphragmatic hernia with a prolapse of a part of the liver into the thorax in one animal is not caused by the test item
administration.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 p.o. rat is therefore > 300 and < 2000 mg/kg b.w.
In accordance with the results of this acute oral toxicity study and in compliance with the criteria of Annex 6 to Directive 2001/59/EU of August 06, 2001 D6 must be classified as harmful (symbol of danger: Xn) and must be Iabelled with R22 "Harmful if swallowed".