Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a strong acid (pH ≤2.0) or base (pH =>11.5)
Cross-referenceopen allclose all
Reason / purpose:
data waiving: supporting information
Reference
Name:
2-Butyne-1,4-diol, reaction products with 1,2-oxathiolane 2,2-dioxide and sodium hydroxide
Implementation:
EU
Type of classification:
self-classification
Related composition:
Composition 2
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Hazard category:
Skin Corr. 1C
Hazard statement:
H314: Causes severe skin burns and eye damage.
Hazard category:
Eye Damage 1
Hazard statement:
H318: Causes serious eye damage.
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Signal word:
Danger
Code:
GHS05: corrosion
Hazard statement:
H314: Causes severe skin burns and eye damage.
Precautionary statement:
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
Precautionary statement:
P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
Precautionary statement:
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Precautionary statement:
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
Precautionary statement:
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
Precautionary statement:
P310: Immediately call a POISON CENTER/doctor/…
Precautionary statement:
P405: Store locked up.
Precautionary statement:
P501: Dispose of contents/container to ...
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Information was taken from the company's in-house analytical summary. As it is necessary to determine the product's specification correctly, it is concluded that the results are sufficiently reliable for assessment.
Qualifier:
no guideline followed
Principles of method if other than guideline:
pH was determined
GLP compliance:
no
pH value:
13.2
Concentration:
43.6 vol%
pH value:
12.6
Concentration:
43.6 vol%
Conclusions:
A 43.6% solution of 2-Butyne-1,4-diol, reaction products with 1,2-oxathiolane 2,2-dioxide and sodium hydroxide in water has a pH value of 13.2 and 12.6 (two independent determinations). Information is expected to have been gathered scientifically reasonable, and it can be concluded that the solution exhibits corrosive effects.
Executive summary:

The pH of a 43.6% solution of 2-Butyne-1,4-diol, reaction products with 1,2-oxathiolane 2,2-dioxide and sodium hydroxide in water was determined as 13.6 resp. 12.6 in two independent experiments.

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
pH was measured with pH meter
GLP compliance:
no
Key result
pH value:
12.2
Concentration:
43.6 vol%
Conclusions:
A 43.6% solution of 2-Butyne-1,4-diol, reaction products with 1,2-oxathiolane 2,2-dioxide and sodium hydroxide in water has a pH value of 12.2. Information was gathered scientifically reasonable, and it can be concluded that the solution exhibits corrosive effects.
Executive summary:

The pH of a 43.6% solution of 2-Butyne-1,4-diol, reaction products with 1,2-oxathiolane 2,2-dioxide and sodium hydroxide in water was determined as 12.2 using a pH meter.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion