Registration Dossier
Registration Dossier
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EC number: 210-431-8 | CAS number: 615-50-9
Endpoint summary
Administrative data
Description of key information
The substance was shown to be slightly irritant for skin rabbit but it was not classified.
The acute eye irritation of Toulene-1,5-Diamine on rabbit eye was determined following procedure described by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42
The study was designed to evaluate the irritant effect of 2.5% w/v solution of Toulene-2,5-diamine (prepared as aqueous solution containing 0.05% sodium sulphite (pH 7.0)) to the rabbit eye
3 rabbits were instilled with 2.5% w/v solution of test substance (containing 0.05% sodium sulphite (pH - 7.0) into one eye. The untreated eye served as control. The eyes were washed with 50 mL lukewarm water (37°C) 10 sec after instillation of the test substance. Animals were examined for ocular reaction at 1 h, Day 1, 2, 3, 4 and 7.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data provided, not enough details to warrant Klimisch rating 1
- Qualifier:
- according to guideline
- Guideline:
- other: The Code of Federal Regulations 16 CFR 1500.41 (Method of testing primary irritant substances)
- Deviations:
- yes
- Remarks:
- only three rabbits were used against six as recommended by guideline.
- GLP compliance:
- no
- Remarks:
- pre GLP
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Details on test animals & environmental conditions are not provided in the report
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- containing 0.05% sodium sulphite (pH 7.0)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5mL
- Concentration: 2.5% w/v
VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported - Duration of treatment / exposure:
- 24 h
- Observation period:
- Two observation were taken at 24 and 72h from onset of exposure
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: The test material was applied on the intact and abraded skin.
SCORING SYSTEM:
Erythema and eschar reaction
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Remarks:
- left (intact) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 16
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 16
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- other: (Left) Intact and (right) abraded skin site
- Irritant / corrosive response data:
- - Very slight erythema with and without very slight oedema was observed in the intact and abraded sites of one animal at the 24 h reading.
- Animals did not show any observable response to treatment throughout the 72 h observation period.
- Calculated Primary irritation index (PII): 0.3 - Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The primary irritation index of Toluene-2,5-diamine, 2.5% w/v solution was calculated to be: 0.3; and was determined to be slightly irritating to rabbit skin.
- Executive summary:
Irritant effects of Toulene-1,5-Diamine on rabbit skin was determined following Method of testing primary irritant substances. The Code of Federal Regulations, Title 16, Section 1500.41
The study was designed to evaluate the irritant effect of Toluene-2,5-diamine to the abraded and intact skin of three albino rabbits, clipped free of hair.
The 2.5% w/v solution of Toulene-2,5-diamine (prepared as aqueous solution containing 0.05% sodium sulphite (pH 7.0)) was applied on (Left) Intact and (right) abraded skin site for the 24-hour period of exposure.
After 24 hours exposure, the patches were removed and observed forerythema and oedema formation. The readings were made at 24h and 72h from onset of exposure.
Very slight erythema with very slight oedema was observed in the intact site of one animal, while very slight oedema was observed at abraded skin site of same animal at the 24 h reading. However, these reactions reversed at 72h reading.
The other two animals did not show any observable response to treatment throughout the 72h of observation period. Therefore it was concluded that the test substance "Toulene-2,5-diamine" is very slightly irritating to rabbit skin.
Based on the above, the primary irritation index of Toluene-2,5-diamine, 2.5% w/v solution was calculated to be 0.3 and was determined to be slightly irritating to rabbit skin
Reference
Table 1: Skin irritation potential of toluene-2,5-diamine, 2.5% w/v solution in rabbits (Study # 71167)
Rabbit no. |
Reaction |
24h |
72h |
||
Left intact |
Right abraded |
Left intact |
Right abraded |
||
1 |
Erythema |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
|
2 |
Erythema |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
|
3 |
Erythema |
1 |
1 |
0 |
0 |
Oedema |
1 |
0 |
0 |
0 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data provided, not enough details to warrant Klimisch rating 1
- Qualifier:
- according to guideline
- Guideline:
- other: The Code of Federal Regulations, Title 16, Section 1500.42 (Test for eye irritants)
- Deviations:
- yes
- Remarks:
- only three rabbits were used against six as recommended by guideline. Eyes were washed 10 sec after instillation of test substance (eyes can be washed after 24 h reading as per the guideline)
- GLP compliance:
- no
- Remarks:
- (pre-dates GLP)
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Details on test animals & environmental conditions are not provided in the report.
- Vehicle:
- water
- Remarks:
- (containing 0.05% sodium sulphite (pH 7.0))
- Controls:
- other: Additional control animals are not required. Eye which did not receive any test substance served as control
- Amount / concentration applied:
- - Concentration: 2.5 % w/v
VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported - Duration of treatment / exposure:
- 10 sec
- Observation period (in vivo):
- 1 h and once daily for Day 1, 2, 3, 4 and Day 7
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Eyes were washed with 50 mL of lukewarm (37°C) water 10 seconds after instillation of the test substance.
- Time after start of exposure: 10 Sec.
SCORING SYSTEM:
U.S. Department of Health, Education and Welfare. Food and Drug Administration Washington. D.C. 20204. “The illustrated Guide for Grading Eye Irritation by Hazardous Substances"
CorneaNo ulceration or opacity: ----------------------------------------------------------------------------- 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible: -----------1
Easily discernible translucent areas, details of iris slightly obscured: ---------------------------------------------- 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: -------------------------------------------3
Complete corneal opacity, iris not discernible: ------------------------------------------------------------------4
Iris
Normal: ----------------------------------------------------------------------------------------------------0
Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of those or combination of any thereof), iris still reacting to light (sluggish reaction is positive): -----------------------------------------------------------------------------1*
No reaction to light, haemorrhage, gross destruction (any or all of these): ------------------------------------------2
Conjunctivae
Redness: (Refers to palpobral and bulbar conjunctivae excluding cornea and iris)
Vessels normal: ----------------------------------------------------------------------------------------------0
Some vessels definitely injected: ------------------------------------------------------------------------------ 1
Diffuse, crimson red, individual vessels not easily discernible: ----------------------------------------------------- 2*
Diffuse beefy red: -------------------------------------------------------------------------------------------- 3
Chemosis
No swelling: --------------------------------------------------------------------------------------------------0
Any swelling above normal (including nictating membrane): --------------------------------------------------------1
Obvious swelling with partial eversion of lids: --------------------------------------------------------------------2*
Swelling with lids about half closed: -----------------------------------------------------------------------------3
Swelling with lids more than half closed: -------------------------------------------------------------------------4
*Bracketed figure indicate lowest grades s considered positive under Title 16, Section 15100.42 of the Code of federal Regulations.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: Not reported - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- Under the conditions of this test, a 2.5% toluene-2,5-diamine solution caused slight irritation to rabbit eyes.
- Executive summary:
The acute eye irritation of Toulene-1,5-Diamine on rabbit eye was determined following procedure described by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42
The study was designed to evaluate the irritant effect of 2.5% w/v solution of Toulene-2,5-diamine (prepared as aqueous solution containing 0.05% sodium sulphite (pH 7.0)) to the rabbit eye
3 rabbits were instilled with 2.5% w/v solution of test substance (containing 0.05% sodium sulphite (pH - 7.0) into one eye. The untreated eye served as control. The eyes were washed with 50 mL lukewarm water (37°C) 10 sec after instillation of the test substance. Animals were examined for ocular reaction at 1 h, Day 1, 2, 3, 4 and 7.
None of the animals gave positive reaction. Mild conjunctival inflammation was observed in 2 animals (score 1) on Days 1 and 3 respectively.
Under the conditions of this test, a 2.5% toluene-2,5-diamine solution caused slight irritation to rabbit eyes.
Reference
Table 1: Numerical scores awarded to the ocular reactions elicited by toluene-2,5-diamine (study # 71168)
Animal No. |
Region of eye |
1h |
Day |
Positive (+) or Negative (-) |
||||
1 |
2 |
3 |
4 |
7 |
||||
1 |
Cornea |
|
0 |
0 |
0 |
0 |
0 |
Negative (-) |
Iris |
|
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
0 |
0 |
1 |
0 |
0 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
2 |
Cornea |
|
0 |
0 |
0 |
0 |
0 |
Negative (-) |
Iris |
|
0 |
0 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
0 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
3 |
Cornea |
|
0 |
0 |
0 |
0 |
0 |
Negative (-) |
Iris |
|
0 |
1 |
0 |
0 |
0 |
||
Conjunctiva |
Redness |
0 |
0 |
0 |
0 |
0 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
- None of the animals gave a "positive" reaction.
- Mild conjunctival inflammation only was observed in two animals on days one and three respectively.
- The third animal did not show any observable response to treatment.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
reliability 1
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Under CLP criteria, the substance is classifed as eye irritant Eye irrit. Cat. 2 ; H319 according to CLP criteria.
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.
