Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene

Endpoint summary

Description of key information

oral (rat): > 5000 mg/kg bw (m+f)
dermal (rat): > 2000 mg/kg bw (m+f)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4.11.-18.11.1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP (performed 1982), comparable to OECD guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): TK 12340
- Substance type: organic
- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tiertarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 170-221 g
- Fasting period before study: overnight prior to dosing
- Housing: 5 animals per Macrolon cage type 3 with standardized soft wood bedding (Societe Parisienne dessciures, Pantin)
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±15
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observation: Mortality: daily, a.m. and p.m. on working days. Clinical signs: daily. Body weight: on days 1, 7, 14, and at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: sedation, dyspnea, exophtalmus, ruffled fur, and curved body position; body weight

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality occurred.

Mortality:

No mortality occurred.

Clinical signs:

other: The animals recovered within 13 days.

Gross pathology:

No compound related gross organ changes were observed.

SIGNS AND SYMPTOMS

Observations

Exposure day: hours

Days of post-exposure period

1

2

3

5

1

2

3

4

5

6

7

8

9

10

11

12

13

>13

5000mg/kg

sedation

xx

xx

xx

xx

dyspnoea

x

x

x

x

x

x

x

x

x

x

x

x

x

x

exophtalmus

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

ruffled fur

xx

xx

xx

xx

xx

x

x

x

x

x

x

x

x

x

x

body position-curved

x

x

x

xx

x

x

x

x

x

x

Interpretation of results:

GHS criteria not met

Conclusions:

CAS 68411-46-1 did not cause mortality when administered orally at a single dose of 5000 mg/kg bw to the albino rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP (performed 1988), only summary report, acceptable because no mortality occured

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Body weight not controlled. No information on housing conditions.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Lot/batch No.: EN-127 506.82

Species:

rat

Strain:

other: albino

Sex:

male/female

Type of coverage:

not specified

Vehicle:

not specified

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred

Mortality:

No mortality was observed.

Clinical signs:

other: Piloerection, abnormal body positions, and dyspnea were seen, being common symptoms in acute toxicity testing. The animals recovered within 9 days.

Gross pathology:

No adverse findings noted.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance caused no mortality when administered dermally at a single dose of 2000 mg/kg bw to the albino rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

The substance was tested for acute toxicity via oral and dermal application to rats.

An LD50 of > 5000 mg/kg bw was identified via oral application for rats. The substance-related symptoms recorded were a slight sedation (for 5 hours), dyspnoea (until day 10), slightly ruffled fur (until day 11), exophthalmus (until day 12), and a curved body position (until day 6). These symptoms are common in acute testing and indicate no special hazard. It was found to be non acute toxic via dermal application. LD50 value of > 2000 mg/kg bw was identified in rats.

Justification for classification or non-classification

There are conclusive but not sufficient data for classification of EC 270 -128 -1 with regard to acute toxicity. The substance is not classified for acute toxicity via oral or dermal route in accordance to the CLP Regulation (EC) No 1272/2008.