Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-044-8 | CAS number: 91-15-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets scientific standards with acceptable restrictions (limited documentation)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
- Principles of method if other than guideline:
- Skin irritation was tested using an internal standard method (BASF test). Two White Vienna rabbits were used. One side of the back was treated for 20 h and the other side was treated for 1, 5 or 15 min under occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened with test substance.
- GLP compliance:
- no
Test material
- Reference substance name:
- Phthalonitrile
- EC Number:
- 202-044-8
- EC Name:
- Phthalonitrile
- Cas Number:
- 91-15-6
- Molecular formula:
- C8H4N2
- IUPAC Name:
- benzene-1,2-dicarbonitrile
- Details on test material:
- - Name of test material (as cited in study report): phthalonitrile
- Analytical purity: purity of the substance is not documented
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 2.75 and 3.03 kg
no further details
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 1 ml
- Concentration (if solution): 50%, creamy solution - Duration of treatment / exposure:
- Experiment 1: 20 h
Experiment 2: 1, 5, or 15 minutes - Observation period:
- 4 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: An application site of 2.5 X 2.5 cm was covered with the liquid (presumably 1 ml suspension)
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Experiment 1: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol conc. and 50% (mild detergent) was used.
Experiment 2: No washing was done after the 20 h treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 20 h exposure
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 d
- Remarks on result:
- other: mean score for animal 1: 0.66; animal 2 without effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 20 h exposure
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 15 min exposure
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 15 min exposure
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Reversibility:
- other: no effect
Any other information on results incl. tables
Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation. Descriptive scores of the raw data have been converted to Draize numerical scores.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
This study meets scientific standards with acceptable restrictions (limited documentation). Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. 2 animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the test substance.
The test substance induced questionable erythema after 20 h occlusive exposure in 1/2 animals, which was reversible within 4 d. 15 min exposure did not cause any irritation effects.
Conclusions
Following the conditions of the test, o-phthalodinitrile is not considered as skin irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
