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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:
18 August 1988 to 1st September 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

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
Reference substance name:
Reference substance 003
EC Number:
611-563-2
Cas Number:
57635-48-0
Details on test material:
- Physical state: clear yellow liquid

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) limited
- Age at study initiation: young adult, 4-7 weeks
- Housing: in single sex groups of five
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 59-74
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The supplied material was formulated in distilled water to archive a dose volume of 10 mg/Kg bodyweight at a dose level of 2000 mg/L
Doses:
dose level: 2000 mg/kg bw; dose volume of 10 mL/kg bodyweight
No. of animals per sex per dose:
Five male and five female animals
Control animals:
no
Details on study design:
All animals were examined frequently after dosing and then daily for fourteen consecutive days. Any signs of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed on Day 1, 8 abd 15.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
no mortalities
Mortality:
No animals died
Other findings:
Piloerection was observed in all animals from within 30 minuts of dosing until four hours.
Transient peribuccal staining was additionally present in one female within 30 minuts of dosing. No other effects of observed during the study. At necropsy a white waxy plug was observed in the bladder of one male and fluid distension of the uterus was noted in one female.

Any other information on results incl. tables

Bodyweights - Individual values

 Dose level mg/kg  Animal nº  Sex  1 Day (g)  8 Day (g)  15 Day (g)  change in bw Day 1 -15
 2000  1  M  122 194  246  124 
2000  2  M  122 171  220  98 
 2000  3  M  124 177  223  99 
 2000  4  M  122 186  249  127 
 2000  5  M  119 177  221  102 
 2000  Mean  M  122 181  232  110 
 2000  S.D  M  1.8 9.0  14.4  14.3 
 2000  6  F  116 148  166  50 
 2000  7  F  115 149  173  58 
 2000  8  F  134 166  190  56 
 2000  9  F  130 156  180  50 
 2000  10  F  108 142  166  58 
 2000  Mean  F  121 152  175  54 
 2000  S.D  F  10.9 9.2  10.2  4.1 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material produced no significant toxic effects when administred orally at a dose level of 2000 mg/kg
Executive summary:

The test material was administered orally, as a single dose of 2000 mg/kg bw, by gavage to a group of five male and female albino rats. Animals were observed for a fourteen day period for clinical signs after which surviving animals were killed and a gross necropsy undertaken.

Piloerection was observed in all animals during the four hours immediately following dosing. No other significant effects were noted throughout the study. At necropsy a white waxy plug was observed in the bladder of one male.