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Toxicological information

Acute Toxicity: inhalation

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Administrative data

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.
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.

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.

Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
dermal absorption
Type of information:
experimental study
Adequacy of study:
supporting study
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
GLP compliance:
no
Radiolabelling:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
no data
Doses:
no data
No. of animals per group:
no data
Conversion factor human vs. animal skin:
no data

The material was not absorbed in acutely toxic amounts.

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.

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.

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
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

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

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.