Amines, polyethylenepoly-, triethylenetetramine fraction

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1951

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

The study was performed pre-GLP and pre-guideline. Limited reporting. No information on the composition or purity of the test substance.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1951

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The study was performed pre-GLP and pre-guideline. Limited reporting. No information on the composition or purity of the test substance.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline available

Principles of method if other than guideline:

Range finding Toxicity study with the registration substance in rats. Oral application 10% aqueous solutions.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: gavage

Vehicle:

water

Doses:

0.3, 1.0, 2.0, 3.0 g/kg bw

No. of animals per sex per dose:

3 and 2 in the low dose sex unknown

Control animals:

no

Sex:

not specified

Dose descriptor:

LD50

Effect level:

>= 1 000 - <= 2 000 mg/kg bw

Based on:

test mat.

Dose (g/kg bw)	No. Died/No. Fed	Remarks
3.0	3/3	Died in 1 day
2.0	2/3
1.0	1/3
0.3	0/2	No effects observed

Interpretation of results:

other: CLP/EU GHS Category 4 (H302) according to Regulation (EC) No 1272/2008

Conclusions:

The LD50 is between 1000 -2000 mg/kg bw based on the results of this study.

Executive summary:

An acute oral toxicity study was performed pre-guideline and pre-GLP with rats of unknown sex. 10% of the test substance in water was administered to the rats in doses of 3.0, 2.0, 1.0 and 0.3 g/kg bw. The LD50 is between 1000 -2000 mg/kg bw based on the results of this study.

Cross-reference 2

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1951

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: The study was performed pre-GLP and pre-guideline. Limited reporting. No information on the composition or purity of the test substance.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline available

Principles of method if other than guideline:

Inhalation was via saturated atmosphere. Three rats per group were tested. In one group the bath temperature was 25°C and the animals were exposed for 8.0 hours. In the second group the bath temperature was 100°C and the animals were exposed for 7.0 hours.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

other: no data

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

not specified

Analytical verification of test atmosphere concentrations:

no

Concentrations:

No data

No. of animals per sex per dose:

3 rats of unknown sex per group

Control animals:

no

Dose descriptor:

LC50

Remarks on result:

not determinable because of methodological limitations

Mortality:

No deaths were observed.

Clinical signs:

other: No other effects were observed.

Other findings:

A strong ammoniacal odor was noticed at 100°C.

Interpretation of results:

study cannot be used for classification

Conclusions:

Acute exposure to the substance vapour for 8 hours (generated at a bath temperature of 25°C) or to substance fume for 7 hours (generated at a bath temperature of 100°C) did not induce toxic effects. No hazard is anticipated from the infrequent inhalation of substantially saturated vapour or fume at room temperature. The results of such a study, however, are not sufficient for classification for acute inhalation toxicity.

Executive summary:

Two groups of 3 rats each (of unknown sex) were exposed to the substance vapour or fume at room temperature. Inhalation was via saturated atmosphere. For one group the bath temperature was 25°C and the animals were exposed for 8.0 hours. For the second group the bath temperature was 100°C and the animals were exposed for 7.0 hours. No deaths were observed and no other effects. A strong ammoniacal odor was noticed.

Cross-reference 3

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1951

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline available

GLP compliance:

no

Remarks:

pre-GLP

Species:

rabbit

Strain:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Duration of treatment / exposure:

No data

Observation period (in vivo):

No data

Number of animals or in vitro replicates:

No data

Material	Treatment	Response-remarks
100%	Unwashed	Marked to severe pain, irritation, and permanent corneal damage
100%	Washed H2O	Moderate pain, irritation, and very slight residual corneal damage
10% in water	Unwashed and washed H2O	Very slight to slight pain, irritation and transient corneal injury
1% in water	Unwashed and washed H2O	Very slight initial pain

Interpretation of results:

study cannot be used for classification

Conclusions:

Because necrosis was seen following treatment with the undiluted test substance, classification in Cat. 1 is assumed. Because of unknown exposure duration and unkown observation period etc., a definite classification is not possible.

Executive summary:

The eyes of rabbits were exposed to the test substance undiluted, and at 10% and 1% in water with and without washing the eyes. No further details on the methods. The undiluted test substance is corrosive to the eye and at 1% slight irritation is observed.

Cross-reference 4

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1951

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline available

GLP compliance:

no

Remarks:

pre-GLP

Species:

rabbit

Strain:

not specified

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

no

Duration of treatment / exposure:

1-12 minutes

Observation period:

No data

Number of animals:

No data

Material	Condition of the skin	Number of applications	Site	Response-remarks
100%	Intact	1 for 12 minutes	Belly	Severe hyperemia and slight denaturation
100%	Intact	1 for 6 minutes	Belly	Moderate hyperemia and slight denaturation
100%	Intact	1 for 3 minutes	Belly	Slight hyperemia
100%	Intact	1 for 1 minutes	Belly	No apparent effect
10% in H2O	Intact	10	Ear	Slight hyperemia
10% in H2O	Intact	4	Belly	Severe hyperemia, denaturation and slight edema
1% in H2O	Intact	10	Ear	No apparent effect
1% in H2O	Intact	10	Belly	Slight hyperemia

Interpretation of results:

study cannot be used for classification

Conclusions:

Because of the signs seen after 6 minutes, necrosis following treatment with the undiluted test substance, classification in Cat. 1 could be assumed. Because of unknown exposure duration and unkown observation period, classification in subcategories (1A, 1B, 1C) is not possible.

Executive summary:

The intact skin of belly or ears of rabbits were exposed to the test substance as undiluted, 10% and 1% in water. No further details on the methods. After 6 minutes exposure necrosis is seen.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1953

Report date:

1953

Materials and methods

Test guideline

Qualifier:

no guideline available

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amines, polyethylenepoly-, triethylenetetramine fraction

EC Number:

292-588-2

EC Name:

Amines, polyethylenepoly-, triethylenetetramine fraction

Cas Number:

90640-67-8

Molecular formula:

C6H18N4, C8H20N4

IUPAC Name:

Amines, polyethylenepoly-, triethylenetetramine fraction

Test material form:

liquid

Radiolabelling:

no

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Duration of exposure:

no data

Doses:

no data

No. of animals per group:

no data

Results and discussion

Conversion factor human vs. animal skin:

no data

Any other information on results incl. tables

The material was not absorbed in acutely toxic amounts.

Applicant's summary and conclusion

Conclusions:

The material was not absorbed in acutely toxic amounts.

Executive summary:

Through rabbit skin the material was not absorbed in acutely toxic amounts. No further information.