Registration Dossier

Administrative data

Description of key information

Acute oral toxicity

In an acute toxicity study with 2,2’-(phenylimino)diethanol, five Sprague-Dawley rats per sex per dose were exposed to the test substance dissolved in carboxymethyl cellulose (with 2-3 drops Cremophor EL) via oral gavage. Animals received 1600, 3200, 4000 and 6400 mg/kg bw. After an observation of 7 days animals were necropsied. Immediately after application until 20 minutes after application dyspnea, partly atony and staggering, narcotic-like state, scretion from snounts was observed. All symptoms were absent within 5 days.6400 mg/kg 4/5 females and 2/5 males died within 1 hours, the remaining animlas died within a day, at 4000 mg/kg 1/5 females died within 1 hour, the remaining females died within a day. 2/5 males died within 24 hours, 4/5 males were dead after 7 days. At 3200 mg/kg 3/5 females died within 24 hours, 0/5 males died within 7 days. No death were observed at 1600 mg/kg. Normal body weight gain was observed. Acute heart dilatation and congestive hyperemia, dilated stomach with liquid content, diarrheic intestine content, splenomegaly were observed. The LD50 was ca. 3400 mg/kg bw (BASF SE, 1974).

 

In a second acute toxicity study with 2,2’-(phenylimino)diethanol, one cat per sex per dose was exposed to 50 mg/kg bw of the test substance dissolved in carboxymethyl cellulose (CMC). No mortality was observed.

Clinical signs, like slight cyanosis were reported and the methemoglobin content was determined, according to the spectrophotometrical method of Evelyn and Mallow over a period of 48 hours. 2 - 6 hours after administration a distinct increase of methemoglobin (12 - 32%) in the blood was observed. The increased methemoglobin level returned to normal after 24 - 30 hours after administration (BASF SE, 1974).

Acute inhaltion toxicity

In an inhalation hazard test, six young adult rats per sex were exposed to 0.1 mg/L dust for 8 hours. After an observation of 7 days animals were necropsied. No clinical signs or mortality were observed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Animal experimental study, predates implementation of GLP and/or development of study guidelines, limitations in design and/or reporting but otherwise adequate for assessment
Principles of method if other than guideline:
According to BASF-internal standard: Five Sprague-Dawley rats per sex per dose were exposed to the test substance dissolved in carboxymethyl cellulose (with 2-3 drops Cremophor EL) via oral gavage. Animals received 1600, 3200, 4000 and 6400 mg/kg bw. After an observation of 7 days animals were necropsied.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
- Weight at study initiation: Males: 143 - 169g; Females: 142 - 167g
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
with 2-3 drops Cremophor EL
Details on oral exposure:
The test substance was administered in concentrations of 2, 16 and 30%
Doses:
1600, 3200, 4000 and 6400 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 400 mg/kg bw
Based on:
test mat.
Mortality:
- 1600 mg/kg: no deaths observed
- 3200 mg/kg: 3/5 females died within 24 hours. 0/5 males died within 7 days
- 4000 mg/kg: 1/5 females died within 1 hour, the remaining females died within a day. 2/5 males died within 24 hours, 4/5 males were dead after 7 days.
- 6400 mg/kg: 4/5 females and 2/5 males died within 1 hours, the remaining animlas died within a day
Clinical signs:
Immediately after application until 20 minutes after application dyspnea, partly atony and staggering, narcotic-like state, scretion from snounts was observed. All symptoms were absent within 5 days.
Body weight:
Normal body weight gain was observed.
Gross pathology:
Acute heart dilatation and congestive hyperemia, dilated stomach with liquid content, diarrheic intestine content, splenomegaly were observed.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Animal experimental study, predates implementation of GLP and/or development of study guidelines, limitations in design and/or reporting but otherwise adequate for assessment
Principles of method if other than guideline:
One cat per sex per dose was exposed to 50 mg/kg bw of the test substance dissolved in carboxymethyl cellulose (CMC). Clinical signs were reported and the methemoglobin content was determined, according to the spectrophotometrical method of Evelyn and Mallow over a period of 48 hours.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
cat
Strain:
other: own breeding
Sex:
male/female
Details on test animals and environmental conditions:
- Mean body weight: 2.97 kg
- The animals were offered wet food (Eddie), milk and whale meat.
Route of administration:
oral: gavage
Details on oral exposure:
The test substance was administerd as an 0.5% suspension with CMC.
Doses:
50 mg/kg
No. of animals per sex per dose:
1
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 48 hours
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs; determination of the methemoglobin content according to the spectrophotometrical method of Evelyn and Malloy.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 50 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Slight cyanosis was observed.
Other findings:
- Methemoglobin content: 2 - 6 hours after administration a distinct increase of methemoglobin in the blood was observed. The increased methemoglobin level returned to normal after 24 - 30 hours after administration.

 Dose  Animal (cat)         Methemoglobin (%)        
     2 h 4 h  6 h 24 h  30 h  48 h 
 CMC (conrtol)  male  0 0.2  0.4 
   female  0 0.2 
 50 mg/kg (test substance)  male  11.4 18.4  10.3  0.8  1.9  0.4 
   female  17.8 32.4  30.3  1.0  0.0  0.3 
 50 µl/kg (positive control, anilin)  male  82 81.9  79.1  62.5  41  2.4 
   female  71 77.5  78.8  26.0  1.25  0.5 
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 200 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Animal experimental study, predates implementation of GLP and/or development of study guidelines, limitations in design and/or reporting but otherwise adequate for assessment
Principles of method if other than guideline:
According to BASF-internal standard: Six young adult rats per sex were exposed to 0.1 mg/L dust. After an observation period of 7 days animals were necropsied.
GLP compliance:
no
Test type:
other: inhalation hazard test
Limit test:
no
Species:
rat
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 177 g
Route of administration:
inhalation: dust
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Rate of air: 200 L/h
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
0.1 mg/L
No. of animals per sex per dose:
12
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.1 mg/L air
Based on:
test mat.
Exp. duration:
8 h
Mortality:
No mortality observed.
Clinical signs:
No clinical signs observed.
Gross pathology:
Nothing abnormal detected.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the available studies data on acute toxicity properties the test item have to be classified and labelled as STOT SE cat. 1 (H370, causes damage to organs (blood)) according to Regulation (EC) No 1272/2008 (CLP).