Reaction mass of 2-[[[2-[(2-aminoethyl)amino]ethyl]amino]carbonyl]-benzoic acid and 2,2' -[iminobis(2,1-ethanediyliminocarbonyl)]bis-benzoic acid and 7,8,9,10,11,12,20,21,22,23,24,25-dodecahydrodibenzo[i,t] [1,4,7,12,15,18] hexaazacyclodocosine-5,13,18,26(6H,19H)-tetrone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP study. The experiment was performed according to the guideline equivalent or similar to the OECD 402 (Acute dermal toxicity).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-({2-[(2-aminoethyl)amino]ethyl}carbamoyl)benzoic acid; 2-{[2-({2-[(2-carboxyphenyl)formamido]ethyl}amino)ethyl]carbamoyl}benzoic acid; 3,6,9,18,21,24-hexaazatricyclo[24.4.0.0¹¹,¹⁶]triaconta-1(30),11,13,15,26,28-hexaene-2,10,17,25-tetrone

EC Number:

942-764-6

IUPAC Name:

2-({2-[(2-aminoethyl)amino]ethyl}carbamoyl)benzoic acid; 2-{[2-({2-[(2-carboxyphenyl)formamido]ethyl}amino)ethyl]carbamoyl}benzoic acid; 3,6,9,18,21,24-hexaazatricyclo[24.4.0.0¹¹,¹⁶]triaconta-1(30),11,13,15,26,28-hexaene-2,10,17,25-tetrone

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Type of material: powder.

Test animals

Species:

rabbit

Strain:

other: Albinos rabbits

Sex:

male/female

Details on test animals or test system and environmental conditions:

6 albinos rabbits (3males and 3 females)

Administration / exposure

Type of coverage:

not specified

Vehicle:

other: Test material was applied to premoistened skin.

Duration of exposure:

24 hours

Doses:

300/ 1000 / 3000 mg/g

No. of animals per sex per dose:

Two animals for each dose level (one male and one female)

Control animals:

not specified

Details on study design:

Test item was applied at each dose level on one abraded and one intact animal.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 other: mg/kg

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: The rabbits did not exhibit any unusual behavioral reactions following dermal exposure. Local skin recation after 24-hour exposure period were characterized by barely perceptible pale to red erythema. No skin reaction were noted at 7 and 14 days.

Gross pathology:

Necropsy examination of all rabbits sacrified at the end of the 14-day observation period, did not reveal any gross pathologix alterations.

Any other information on results incl. tables

Mortality and body weight:

Dose* (mg/kg)	Animal N° and sex	Individual bodyweight (kg) at test day 0	Individual bodyweight (kg) at test day 14	Number dead/ Number tested	Percent dead
300	1 -M** 2 -F	2.86 2.64	2.70 2.98	0/2	0
1000	3-M** 4 -F	2.90 2.44	2.80 2.56	0/2	0
3000	5-M** 6 -F	2.98 3.18	2.96 3.14	0/2	0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute LD50 of the test material was determined to be greater than 3000 mg/kg.

Executive summary:

Three males and three females albinos rabbits were used to detemined the acute dermale toxicity of the test material.

Two animals for each dose level (one male and one female): 300 / 1000 and 3000 mg/kg.

Test item was applied at each dose level on one abraded and one intact animal.

The observation period is 14 days after 24 hours exposure duration.

The rabbits did not exhibit any unusual behavioral reactions following dermal exposure. Local skin recation after 24-hour exposure period were characterized by barely perceptible pale to red erythema. No skin reaction were noted at 7 and 14 days.

Necropsy examination of all rabbits sacrified at the end of the 14-day observation period, did not reveal any gross pathologix alterations.

No mortality occured during the observation time.

The acute LD50 of the test material was dezermined to be greater than 3000 mg/kg.