Registration Dossier
Registration Dossier
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EC number: 292-588-2 | CAS number: 90640-67-8
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-referenceopen allclose all
- 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.
- 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.
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 |
- 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.
- 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
- 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.
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 |
- 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
- 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.
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 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 953
- Report date:
- 1953
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
Test material
- 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
Constituent 1
- 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.
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