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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 13, 1981 - December 2, 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
EC Number:
279-632-6
EC Name:
Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
Cas Number:
80939-62-4
Molecular formula:
Unspecified
IUPAC Name:
Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Tierfarm, CH-4332 Sisseln
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 163 - 190 g
- Fasting period before study: over night, prior to dosing
- Housing: groups of 5 in macrolon cages type 3 with standardized soft wood bedding
- Diet: rat food, Nafag No. 890
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
5000 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 or until all symptoms have disappeared, whichever lasts longer
- Frequency of observations: daily
- Frequency of weighing: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
Statistics:
For the body weights, the group means and their standard deviation were calculated.
The LD50 including the 95 % confidence limit were computed by the logit method.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1 female animal died 2 days post application.
Mortality:
1 female animal died 2 days post application.
Clinical signs:
other: Dyspnoea, ruffled fur and curved body position were observed directly after application and lasted up to day 7 post application. For several hours or days, respectivley, sedation and diarrhoea was also observed. All clinical signs were reversible within t
Gross pathology:
No compound related gross organ changes were observed.

Any other information on results incl. tables

Table 1: Body Weights (g) and Standard Deviation

Dose (mg/kg bw)

Day 1

Day 7

Day 14

 

Males

5000

182 (5.8)

206 (9.3)

250 (15.7)

 

Females

5000

171 (5.2)

178 (6.9)

202 ( 5.5)

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Upon an acute oral administration and a 14 day post-treatment observation period, an LD50 of > 5000 mg/kg bw was determined in the rat.