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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 5 January 1987 to 8 January 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
No detail on the test item was provided ( purity, solubility and stability), no details on preparation of test item was provided, the volume of gavage was not given. The non GLP-compliant study did not follow modern standard but give information on the range of the LD50 value.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
No detail on the test item was provided ( purity, solubility and stability), no details on preparation of test item was provided, the volume of gavage was not given.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(2-nitrophenyl)amino]ethanol
EC Number:
225-555-8
EC Name:
2-[(2-nitrophenyl)amino]ethanol
Cas Number:
4926-55-0
Molecular formula:
C8H10N2O3
IUPAC Name:
2-[(2-nitrophenyl)amino]ethanol
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
Batch No. 4250786
No details of the test item was provided in the study.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
No details of the test item was provided in the study.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was used at 10% in suspension in 3% acacia.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Clairol stock colony
- Females (if applicable) nulliparous and non-pregnant: Not specified in the study
- Age at study initiation: not specified
- Weight at study initiation: 180 to 300 mg (males and females)
- Fasting period before study: Animals were fasted for a 24 hours period prior dosing
- Housing: not reported
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: for at least 7 days

ENVIRONMENTAL CONDITIONS
Environmental and housing conditions were not reported in the study report

IN-LIFE DATES: From 12 December 1986 To 8 January 1987

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 3% acacia
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10% of test item in 3% acacia
- Amount of vehicle (if gavage): not reported
- Justification for choice of vehicle: no justification provided
- Lot/batch no. (if required): not specified
- Purity: not specified

MAXIMUM DOSE VOLUME APPLIED: Not specified

DOSAGE PREPARATION (if unusual): test item in suspension in vehicle
Doses:
Three doses were used in this study : 625, 1250 and 2500 mg/kg bw
No. of animals per sex per dose:
Five animals per sex per dose were used in the main study,
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days observation period, If signs of extreme toxicity were noted, the observation period may be extended to 14 days.
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: no
- Other examinations performed: mortality, pharmacologic and toxicologic effects

Results and discussion

Preliminary study:
A preliminary study was performed to determined if the estimated Lethal Dose 50 is above 5000 mg/kg bw in rats. More than one animal died and three groups were selected for dosing at different dose level.
Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 1 250 - < 2 500 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 625 - < 1 250 mg/kg bw
Based on:
test mat.
Mortality:
At the low dose no mortalities were observed, at the mid dose no deaths were seen in the males while 3 of 5 females died within 8 h after dosing. At the high dose all animals died.
Clinical signs:
other: No clinical sign was observed

Any other information on results incl. tables

Table 1 :Summaryof theresults

 

Hours

 

 

 

Days

 

 

 

 

 

 

Dose

0-1

1-3

3-8

8-24

2

3

4

5

6

7

TOTAL

Male

625

0

0

0

0

0

0

0

0

0

0

0/5

1250

0

0

0

0

0

0

0

0

0

0

 

2500

0

0

5

0

0

0

0

0

0

0

5/5

 

 

 

 

 

 

 

 

 

 

 

 

Female

625

0

0

0

0

0

0

0

0

0

0

0/5

1250

0

0

3

0

0

0

0

0

0

0

3/5

2500

0

0

5

0

0

0

0

0

0

0

5/5

 

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
No detail on the test item was provided (purity, solubility and stability), no details on preparation of test item was provided, the volume of gavage was not given. The non GLP-compliant study did not follow modern standard but give information on the range of the LD50 value.
Conclusions:
Under the experimental conditions of this study, the test item induced mortality of all animals at the high dose level. However, in male male, no mortaility was found at 1250 mg/kg bw and 3 females were found dead at this dose level. The LD50 value was below the value of 2500 mg/kg bw and for female was between 625 mg/kg bw and 1250 mg/kg bw. Hence, the test item was classified as Acute Oral Hazard Category 4 according CLP criteria.
Executive summary:

This non-GLP compliant study was performed in order to assess the potential Acute Oral Toxicity of the test item HC Yellow 2 in rats. No detail on the test item was provided (purity, solubility and stability), no details on preparation of test item was provided, the volume of gavage was not given. The non GLP-compliant study did not follow modern standard but give information on the range of the LD50 value in acute oral toxicity test on rats.

A 10% suspension of the test substance in 3% acacia was administered once via oral gavage to groups of 5 male and 5 female rats at the dose levels 625, 1250, and 2500 mg/kg bw. At the low dose no mortalities were observed, at the mid dose no deaths were seen in the males while 3 of 5 females died within 8 h after dosing. At the high dose all animals died.

Under the experimental conditions of this study, the test item induced mortality of all animals at the high dose level. However, in male, no mortaility was found at 1250 mg/kg bw and 3 females were found dead at this dose level. The LD50 value was below the value of 2500 mg/kg bw and for female was between 625 mg/kg bw and 1250 mg/kg bw. Hence, the test item was classified as Acute Oral Hazard Category 4 according to CLP criteria.