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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-01-29 to 1992-02-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of oleic acid, 2-(2-aminoethylamino)-ethanol, epichlorhydrin and bisulfit
Molecular formula:
not available for UVCB
IUPAC Name:
Reaction products of oleic acid, 2-(2-aminoethylamino)-ethanol, epichlorhydrin and bisulfit
Test material form:
solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 5 - 8 weeks old
- Weight at study initiation: males: 126 - 140 g; females: 126 - 134 g
- Fasting period before study: Yes
- Housing: In groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 53 - 63
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
Doses:
2000 mg/kg bw (Dose volume: 1.74 ml/kg bw)
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, other toxicological effects

Results and discussion

Preliminary study:
There were no deaths or clinical signs of toxicity. The results of the range-finding study indicated that the acute oral median lethal dose of the test item was greater than 2000 mg/kg bw. Based on this information, a dose level of 2000 mg/kg bw was selected for the main study.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
Individual clinical observations and mortality data are given in section "Any other information on results incl. tables"
Body weight:
All animals showed expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necroscopy.
Other findings:
None

Any other information on results incl. tables

Table: Individual clinical observations and mortality data in the main study

Dose
Level
mg/kg bw
Animal
Number
& Sex
Effects Noted After Dosing
(Hours)
Effects Noted During Period After Dosing
(Days)
1/2 1 2 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14
2000 3-0
Male
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3-1
Male
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3-2
Male
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3-3
Male
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3-4
Male
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4-0
Female
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4-1
Female
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4-2
Female
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4-3
Female
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4-4
Female
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0 = No signs of systemic toxicity

Table 2: Individual bodyweights and weekly bodyweight gain in the main study

Dose Level
mg/kg
Animal Number
& Sex
Bodyweight (g) at Day Bodyweight Gain (g) During Week
0 7 14 1 2
2000 3-0 Male 137 216 270 79 54
3-1 Male 134 202 254 68 52
3-2 Male 132 209 267 77 58
3-3 Male 140 209 261 69 52
3-4 Male 126 194 254 68 60
4-0 Female 129 170 197 41 27
4-1 Female 126 174 206 48 32
4-2 Female 127 164 197 37 33
4-3 Female 134 187 221 53 34
4-4 Female 128 169 186 41 17

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item in the Spraque-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

A study was performed to assess the acute oral toxicity of the test item in the Spraque-Dawley strain rat according to OECD Guideline 401 and in compliance with GLP principles. Following a range finding study, a group of ten fasted animals, five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bw. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination. In result, there were no deaths. No signs of toxicity were noted during the study. All animals showed expected gain in bodyweight during the study. Thus, the LD50 of the test item was determined to be greater than 2000 mg/kg bw. The test is regared to be valid.