Registration Dossier
Registration Dossier
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EC number: 941-492-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-11-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see "justification for type of information"
- Remarks:
- This read-across is based on the hypothesis that the source and the target substance have similar structural formula, with a similar toxicity profile amongst the raw materials used to synthetized the Sepisol Fast Yellow MG-F and MG-DPG. The target substance is a UCVB characterized qualitatively but not quantitatively, i.e. exact distribution of the various species is not well known. The UVCB is composed of a common core which is identical to the mono-constituent source substance. The source and the target substances share structural similarities with common functional groups varying in their substitutions. Adequate, reliable and available scientific information indicates that the source and target substances would have similar toxicity profiles. Both substances are manufactured according the same manufacturing process, with the same facilities, and will be handled and use in the same ways. The exposure to these 2 substances will be also identical. The source and target substances are also classified in the same way, with the same labelling requirements. Therefore, read-across from the existing eye irritation test on the source substance is considered as an appropriate adaptation to the standard information requirements of Annex VII, 8.2 of the REACH regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH regulation.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
- Remarks:
- Read-accross with a study conduct with the Sepisol fast yellow MG-DPG
Reference
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2012-11-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see "justification for type of information"
- Remarks:
- This read-across is based on the hypothesis that the source and the target substance have similar structural formula, with a similar toxicity profile amongst the raw materials used to synthetized the Sepisol Fast Yellow MG-F and MG-DPG. The target substance is a UCVB characterized qualitatively but not quantitatively, i.e. exact distribution of the various species is not well known. The UVCB is composed of a common core which is identical to the mono-constituent source substance. The source and the target substances share structural similarities with common functional groups varying in their substitutions. Adequate, reliable and available scientific information indicates that the source and target substances would have similar toxicity profiles. Both substances are manufactured according the same manufacturing process, with the same facilities, and will be handled and use in the same ways. The exposure to these 2 substances will be also identical. The source and target substances are also classified in the same way, with the same labelling requirements. Therefore, read-across from the existing eye irritation test on the source substance is considered as an appropriate adaptation to the standard information requirements of Annex VII, 8.2 of the REACH regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH regulation.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The basic structures of the target and the source substances are the same: the target substance is the source substance which is substituted on the phenylamine cycles by 2 methyl groups or 1 ethyl group (see Figure I in the document attached).
Remark: the target and the source substances are manufactured by the same manufacturer, within the same facilities, and the anionic starting raw material used for the synthesis is identical.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source substance (Sepisol fast yellow MG-DPG) and the target substance (Sepisol fast yellow MG-F) share the same impurities and a very close physicochemical properties profile (see table 3 of the attached document)
3. ANALOGUE APPROACH JUSTIFICATION
All the physicochemical properties were determined thank to same method for the 2 sources, and their profile is similar (see attached document). The structural differences in the substitution of the diphenylamine cycles do not significantly influence the physicochemical properties. However, some trends in the physicochemical parameters due to the substitution of the cycles can be observed : for example, while a clear and sharp melting point is observed at 160°C for the source substance (mono-constituent), a softening point with no clear melting is observed at 130°C for the target substance (UVCB). It is consistent with the fact that when substances with close melting point are mixed together, the mixture has a lowered melting point and a broadened melting range.
The solubility of the target substance is lower than the solubility of the source substance, which is consistent with the increase of its molecular weight. The partition coefficient has been calculated from the measured solubilities of the test item in octanol and in water separately: the one of the target substance is higher than the one of the source substance (higher molecular weight so lower solubility and high solubility in octanol) but it remains under the cut-off value of 4.
Comparison of the results of the acute toxicity test performed on the source and the target substance are detailled in the attached document: both have a LD50 between 300 mg/kg and 2000 mg/kg and are classification acute toxicity oral cat. 4.
4. DATA MATRIX
See the attached document. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: eyes from chickens freshly killed
- Details on test animals or tissues and environmental conditions:
- TEST EYES
- Source: Slaughterhouses Etablissement Brun, 33820 Etaulier, France
- Age of the donors animals: approximately 7 weeks old
- Weight of the donors animals: between 1.5 to 2.5 kg
- Transport of eyes: The intact heads were transported from the slaughterhouse at ambient temperature in polystrene boxes humidified with towels moistened with isotonic saline. The eyes are enucleated in the laboratory within less than 1h30 after the the heads are removed
- Time between collection and use of corneas:The corneas were transported to the laboratory straight after removal on animals and used in a maximum delay of 24 hours after reception at the laboratory. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 30 mg - Duration of treatment / exposure:
- Treatment of 10 secondes
- Observation period (in vivo):
- 4 hours post-treatment
- Number of animals or in vitro replicates:
- 3 chicken eyes for the treatment group
3 chicken eyes for the positive control group
1 chicken eye for the negative control group - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 40 mL of physiological saline (4 times for the treatement group and 2 times for the control groups)
- Time after start of exposure: after 10 secondes
SCORING SYSTEM: Determination of ICE classes for 3 endpoints (1- corneal thickness, 2- corneal opacitiy, 3- fluorescein retention) according to a predefine range. Each ICE classes are then combined to generate an Irritancy Classification
TOOL USED TO ASSESS SCORE:
- Corneal thickness : quantitative determination by optical pachymeter on a slit-lamp microscope.
- Corneal opacity: qualitative assessment based on the area of the cornea opacified
- Fluorescein retention : qualitative assessment based on the staining of the cornea - Irritation parameter:
- other: ICE class
- Remarks:
- average values of the evaluation of corneal lesions
- Remarks on result:
- other: ICE class II
- Irritant / corrosive response data:
- Maximal mean corneal swelling score: +10% corresponding to the ICE class II
Maximal mean corneal opacity score: 0.2, corresponding to the ICE class I
Mean score of fluorescein retention: 0.8, corresponding to the ICE class II - Other effects:
- no morphological effects were noted, whatever the examination time
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item SEPISOL FAST YELLOW MG-DPG must not be classified R41 "Risk of serious damage to eyes", according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. The symbol "Xi" and the danger label "irritant" are not required.
In accordance with the Regulation (EC) No. 1272/2008, the test item must not be classified in category l "irreversible effects on the eye". The signal word "Danger" and hazard statement H318 "Causes serious eye damage" are not required. - Executive summary:
The aim of the study was to evaluate the possible ocular corrosive or severe irritating effects of the test item after administration on enucleated chickeh eyes.
The test item SEPISOL FAST YELLOW MG-DPG was applied, as supplied, at the dose of 30 mg, to 3 enucleated chicken eyes, during 10 seconds. Then the eyes were rinsed twice with 10 mL of physiological saline. As there was remaining test item, the eyes were rinsed again twice with 10 mL of physiological saline. Test item remained on the cornea of one eye during all the study and on another eye up to the observation time 2 hours.
Three eyes were treated in the same manner (except for a rinse twice with 10 mL of physiological saline) with a positive control and one eye with a negative control. Damages by the test substance were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120, 180 and 240 minutes post-dose.
The experimental protocol was established in accordance with the O.E.C.D. guideline No 438 adopted 07 September 2009 and the test method B.48 - Commission Regulation (EU) No. 1152/2010 dated 08 December 2010 (EU Journal L324) - ATP Council regulation No 440/2008 of 30 May 2008 (E. U Journal L142).
The ocular reactions observed in eyes treated with the test item were slight to moderate:
- maximal mean score of corneal opacity: 0.2, corresponding to the ICE class I;
- mean score of fluorescein retention: 0.8, corresponding to the ICE class II;
- maximal mean corneal swelling: +10%, corresponding to the ICE class II.
The combination of the three endpoints for the positive control, 10 % sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as corrosive/severe irritant, as expected.
The combination of the three endpoints for the negative control, physiological saline solution, was 3 x I. Therefore, the negative control is classified as non corrosive/severe irritant, as expected.
The results obtained, under these experimental conditions, enable to conclude that the test item SEPISOL FAST YELLOW MG-DPG must not be classified R41 "Risk of serious damage to eyes", according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. The symbol "Xi" and the danger label "irritant" are not required.
In accordance with the Regulation (EC) No. 1272/2008, the test item must not be classified in category l "irreversible effects on the eye". The signal word "Danger" and hazard statement H318 "Causes serious eye damage" are not required.
Study acceptance criteria:
The concurrent negative and positive controls give an Irritancy Classification that falls within non irritant and severe irritant/corrosive classes, respectively.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 941-151-0
- EC Number:
- 941-151-0
- IUPAC Name:
- 941-151-0
- Reference substance name:
- anilino(phenylimino)methanaminium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- IUPAC Name:
- anilino(phenylimino)methanaminium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Reference substance name:
- Sepisol Fast Yellow MG-DPG
- IUPAC Name:
- Sepisol Fast Yellow MG-DPG
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Sepisol Fast Yellow MG-DPG
- Substance type: Organic salt
- Stability under test conditions: Stable
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- other: eyes from chickens freshly killed
- Details on test animals or tissues and environmental conditions:
- TEST EYES
- Source: Slaughterhouses Etablissement Brun, 33820 Etaulier, France
- Age of the donors animals: approximately 7 weeks old
- Weight of the donors animals: between 1.5 to 2.5 kg
- Transport of eyes: The intact heads were transported from the slaughterhouse at ambient temperature in polystrene boxes humidified with towels moistened with isotonic saline. The eyes are enucleated in the laboratory within less than 1h30 after the the heads are removed
- Time between collection and use of corneas:The corneas were transported to the laboratory straight after removal on animals and used in a maximum delay of 24 hours after reception at the laboratory.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 30 mg - Duration of treatment / exposure:
- Treatment of 10 secondes
- Observation period (in vivo):
- 4 hours post-treatment
- Number of animals or in vitro replicates:
- 3 chicken eyes for the treatment group
3 chicken eyes for the positive control group
1 chicken eye for the negative control group - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 40 mL of physiological saline (4 times for the treatement group and 2 times for the control groups)
- Time after start of exposure: after 10 secondes
SCORING SYSTEM: Determination of ICE classes for 3 endpoints (1- corneal thickness, 2- corneal opacitiy, 3- fluorescein retention) according to a predefine range. Each ICE classes are then combined to generate an Irritancy Classification
TOOL USED TO ASSESS SCORE:
- Corneal thickness : quantitative determination by optical pachymeter on a slit-lamp microscope.
- Corneal opacity: qualitative assessment based on the area of the cornea opacified
- Fluorescein retention : qualitative assessment based on the staining of the cornea
Results and discussion
In vitro
Results
- Irritation parameter:
- other: ICE class
- Remarks:
- average values of the evaluation of corneal lesions
- Remarks on result:
- other: ICE class II
In vivo
- Irritant / corrosive response data:
- Maximal mean corneal swelling score: +10% corresponding to the ICE class II
Maximal mean corneal opacity score: 0.2, corresponding to the ICE class I
Mean score of fluorescein retention: 0.8, corresponding to the ICE class II - Other effects:
- no morphological effects were noted, whatever the examination time
Any other information on results incl. tables
Study acceptance criteria:
The concurrent negative and positive controls give an Irritancy Classification that falls within non irritant and severe irritant/corrosive classes, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item SEPISOL FAST YELLOW MG-DPG must not be classified R41 "Risk of serious damage to eyes", according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. The symbol "Xi" and the danger label "irritant" are not required.
In accordance with the Regulation (EC) No. 1272/2008, the test item must not be classified in category l "irreversible effects on the eye". The signal word "Danger" and hazard statement H318 "Causes serious eye damage" are not required. - Executive summary:
The aim of the study was to evaluate the possible ocular corrosive or severe irritating effects of the test item after administration on enucleated chickeh eyes.
The test item SEPISOL FAST YELLOW MG-DPG was applied, as supplied, at the dose of 30 mg, to 3 enucleated chicken eyes, during 10 seconds. Then the eyes were rinsed twice with 10 mL of physiological saline. As there was remaining test item, the eyes were rinsed again twice with 10 mL of physiological saline. Test item remained on the cornea of one eye during all the study and on another eye up to the observation time 2 hours.
Three eyes were treated in the same manner (except for a rinse twice with 10 mL of physiological saline) with a positive control and one eye with a negative control. Damages by the test substance were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120, 180 and 240 minutes post-dose.
The experimental protocol was established in accordance with the O.E.C.D. guideline No 438 adopted 07 September 2009 and the test method B.48 - Commission Regulation (EU) No. 1152/2010 dated 08 December 2010 (EU Journal L324) - ATP Council regulation No 440/2008 of 30 May 2008 (E. U Journal L142).
The ocular reactions observed in eyes treated with the test item were slight to moderate:
- maximal mean score of corneal opacity: 0.2, corresponding to the ICE class I;
- mean score of fluorescein retention: 0.8, corresponding to the ICE class II;
- maximal mean corneal swelling: +10%, corresponding to the ICE class II.
The combination of the three endpoints for the positive control, 10 % sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as corrosive/severe irritant, as expected.
The combination of the three endpoints for the negative control, physiological saline solution, was 3 x I. Therefore, the negative control is classified as non corrosive/severe irritant, as expected.
The results obtained, under these experimental conditions, enable to conclude that the test item SEPISOL FAST YELLOW MG-DPG must not be classified R41 "Risk of serious damage to eyes", according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. The symbol "Xi" and the danger label "irritant" are not required.
In accordance with the Regulation (EC) No. 1272/2008, the test item must not be classified in category l "irreversible effects on the eye". The signal word "Danger" and hazard statement H318 "Causes serious eye damage" are not required.
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.
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