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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-01-07 to 1986-01-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline conform study, conducted under GLP principles, with very minor deficiencies when compared to contemporary standards: the purity and the stability of the test material were not stated in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981-05-12
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Rezal 67 solution
- Label: Ref.QC 751E REZAL 67 SOLUTION
- Physical state: pale straw coloured liquid
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately five to eight weeks old
- Weight at study initiation: males: 110 - 139 g; females: 109- 137 g
- Fasting period before study: an overnight fast immediately before dosing and for approximately two hours after dosing
- Housing: the animals were housed in polypropylene cages with sawdust bedding.
- Diet (ad libitum, for exception see "Fasting period before study" above): Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.
- Water (ad libitum, for exception see "Fasting period before study" above): mains drinking water
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 22°C
- Relative humidity: 45 - 60%
- Air changes: approximately 15 changes per hour
- 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: 1.55 mL/kg; for the purpose of this study the specific gravity (1.292), as given by the study sponsor, was used to calculate the appropriate dose volume for the required dose level.
The dose level for each animal was calculated according to its bodyweight at the time of dosing.



Doses:
2000 mg/kg
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: animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Mortalities and evidence of overt toxicity were recorded at each observation.
Individual bodyweights were recorded on the day of treatment (day 0) and days 7 and 14.
- Necropsy of survivors performed: yes; all animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained.
Statistics:
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
All animals showed hunched posture, pilo-erection, lethargy and a decreased respiratory rate one hour after treatment. Additional signs of toxicity observed in some animals one hour after treatment consisted of increased salivation and staining around the mouth and/or snout. Hunched posture, pilo-erection and lethargy continued to be observed in all animals at the four hour observation. On day one all animals remained hunched and pilo-erected. All animals appeared normal by day two with the exception of three animals which remained hunched and pilo-erected; recovery of these animals was complete by day three.
Body weight:
Normal bodyweight gains were recorded during the study period.
Gross pathology:
All animals were subjected to gross necropsy. An area of thickening approximately 4 mm X 4 mm on the glandular region of the stomach was recorded for a single female rat. No abnormalities were seen in any of the remaining animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of Rezal 67 solution to the rat was found to be greater than 2000 mg/kg bodyweight.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the oral route.
According to the EC-Regulation 1272/2008 and its subsequent amendments, the test item is not classified as acute toxic via the oral route.