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Toxicological information

Acute Toxicity: oral

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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
Study period:
2 February 1990 - 20 February 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test was performed according to guideline and under GLP. No deviations. Test substance is without acetate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Testsubstance is the same as defined in section 1 but without the acetate: it only contains the alkoxypropanediamine and not the alkoxypropanediamine acetate.

Lilaflot D 817
Description: colourless, slightly viscous liquid
Container: glass screw-top bottle
Storage conditions: room temperature

Test material data sheet attached to report:
Chemical name: N-alkyloxy-1,3-propane diamine
mp < 0 deg.C
bp > 100 deg.C
Specific gravity: 800 kg/m3
RO (CH3)3 NH (CH3)3 NH2
alkyl = triisodecyl 1,3-Propanediamine, N1-(3-(tridecyloxy)propyl)-, branched
CAS: 68479-04-9

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin & Kingman Ltd., England
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males: 120-146g and females 129-140g
- Fasting period before study: overnight
- Housing: animals were housed in groups of up to six by sex in solid-floor polypropylene cages with sawdust bedding.
- Diet (e.g.ad libitum ): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 44-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2 February 1990 To: 20 February 1990

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: depends on dose level between 2.5 and 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

DOSAGE PREPARATION (if unusual): For the purpose of this study the test material was freshly prepared, as required, at the appropriate concentration as a solution in arachis oil B.P
Doses:
range finding study:
2000, 200 and 25 mg/kg bw

main study:
200 mg/kg bw
No. of animals per sex per dose:
Range finding:
2

Main study:
5
Control animals:
no
Details on study design:
range finding:
- Duration of observation period following administration: 5 days
- Frequency of observations and weighing: on the day of dosing animals were weighed
- Necropsy of survivors performed: no
- Other examinations performed: none

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation. Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: none
Statistics:
none

Results and discussion

Preliminary study:
In the range finding study all rats died at 2000 mg/kg bw on day 1 and one male animals died on day 4.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Mortality:
In the main study a limit test was performed with doses of 200 mg/kg bw none of the animals died.
Clinical signs:
Signs of toxicity were confined to hunched posture and pilo-erection.
Body weight:
All animals showed expected gain in bodyweight during the study period.
Gross pathology:
No abnormalities were noted at necropsy of animals killed at the end of the study.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral median lethal dose (LD50) o f the test material, LILAFLOT D817, to the Sprague-Dawley strain rat was found to be greater than 200 mg/kg but less than 2000 mg/kg bodyweight. At 200 mg/kg bw 1/14 animals died. LD50 is expected to be > 300 mg/kg: The classification under GHS is Toxicity Category IV.
Executive summary:

A study was performed, according to OECD 401 and under GLP, to determine the acute oral median lethal dose (LD50) of the test material, administered as a solution in arachis oil B.P. in the Sprague-Dawley strain rat . In a range-finding study (2000, 200 and 25 mg/kg bw, 2 animals sex dose) all animals were found dead the next day at 2000 mg/kg bw and one animal died at 200 mg/kg bw at day 4. Following these results a group of ten fasted animals (five males and five females) was given a single oral dose of test material preparation at a dose level of 200 mg/kg bodyweight. There were no deaths. Signs of toxicity were confined to hunched posture and pilo-erection observed 4 hrs after dosing in all animals and on day one in one male. All animals showed expected gain in bodyweight during the study period. No abnormalities were noted at necropsy of animals killed at the end of the study . The acute oral median lethal dose (LD50) o f the test material, LILAFLOT D817, to the Sprague-Dawley strain rat was found to be greater than 200 mg/kg but less than 2000 mg/kg bodyweight. Formal classification under GHS is not possible, but LD50 is expected >= 300 mg/kg, using a LD50 cut-off level of 500 mg/kgbw seems appropriate.