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Diss Factsheets

Administrative data

Description of key information

m-Toluidine induced slight irritational effects in skin and eyes; not relevant for classification.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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: no details given, nevertheless it can be taken for assessment
Principles of method if other than guideline:
Method: 6 animals, clipped areas of the back (intact skin), 0.5 ml undiluted test material/animal, 24 h, semiocclusive, reading time: at removal and after 48 h.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml undiluted test material
Duration of treatment / exposure:
24 hours
Observation period:
up to 48 hours post initial application
Number of animals:
6
Details on study design:
Albino rabbits were clipped free of hair on the trunk and lateral area and were placed in FDA-type stocks. Doses of 9.5 ml of undiluted test material was applied to intact skin under gauze squares. Rubber sheeting was loosely wrapped around the treated area, secured with adhesive tape. After 24 hours the rabbits were removed from the stocks, the patches taken off and the reactions observed. Observations were also made at 48 hours.
Irritation parameter:
other: erythema and edema
Basis:
other: --erythema: mild in 5/6 rabbits and slight in 1/6 rabbits; --no edema in 6/6 rabbits
Time point:
other: 24 hours
Reversibility:
other: see observation time point 48 hours
Remarks on result:
other: scores not available
Irritation parameter:
other: erythema and edema
Basis:
other: slight erythema in 6/6 rabbits but none of 6/6 rabbits show edema
Time point:
other: 48 h
Remarks on result:
other: scores were not given
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at 24 and 48 hrs.
Remarks on result:
other: no edema was observed during the 48 hour observation time
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at 48 hours
Remarks on result:
other: no edema was observed during the 48 hour observation time
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other: not measured/tested
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
4
Reversibility:
other: 48 hours. slight erythema in 6/6 rabbits
Remarks on result:
other: 24 hours: mild erythema in 5/6 rabbits and slight erythema in 1/6 rabbits
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
>= 0
Max. score:
4
Reversibility:
other: 48 hours. slight erythema in 6/6 rabbits
Remarks on result:
other: 48 hours. slight erythema in 6/6 rabbits
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other: not measured/tested
Remarks on result:
not measured/tested
Irritant / corrosive response data:
24 hours: mild erythema in 5/6 rabbits and slight erythema in 1/6 rabbits
48 hours: slight erythema in 6/6 rabbits
no edema was observed during the 48 hour observation time
Other effects:
24 hours: mild erythema in 5/6 rabbits and slight erythenma in 1/6 rabbits
48 hours. slight erythema in 6/6 rabbits
no edema was observed during the 48 hour observation time

m-Toluidine produced slight-mild skin irritation in 24 hours and slight skin irritation in 48 hours when tested on shaved intact skin of rabbits and was not fully reversible in this 48 hour observation time.

Interpretation of results:
GHS criteria not met
Executive summary:

When applied to the clipped intact skin of the back of rabbits undiluted m-toluidine produced mild to slight skin irritation in 24 hours and slight skin irritation in 48 hours. Due to the short observation time of 48 hours the slight effects were observed throughout the entire observation period but are not relevant for classification (DuPont De Nemours 1980).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Although scores were not given, reporting is sufficient to assess the test material
Principles of method if other than guideline:
Method: 2 animals, instillation of 0.1 ml undiluted test material into conjunctival sac, observation period up to 14 d
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye served as control
Amount / concentration applied:
one-tenth milliliter
Duration of treatment / exposure:
the test-eye of 1 rabbit was washed after 20 seconds; the other test-eye of the second rabbit was not washed
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
2
Details on study design:
one-tenth milliliter of undiluted test material was placed into the right concunctival sac of each of 2 male albino rabbits.
after 20 seconds 1 treated eye was wached with tap water for 1 minutes. the treated eye of the other rabbbit was not washed.
Observations of the cornea, iris and concunctiva were made with an ophthamoscope at 1 and 4 hours and at 1, 2, 3, 7 and 14 days ;
Fluor-1 -strip stin and a slit-lamp biomicroscope were used at examinations after the day of treatment.
Irritation parameter:
other: overall irritation
Basis:
animal #1
Time point:
other: overall
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: eye not washed:----- cornea: generalized area of slight cloudiness 1hr- 3 days; -----iris: no effects; -----conjunctivae: (1) redness mild 1 hr-3 days, (2) swelling: mild 1-4 hrs, (3) discharge: copious 1-4 hrs
Irritation parameter:
other: overall irritation
Basis:
animal #2
Time point:
other: overall
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: eye washed: -cornea: generalised slight cloudiness up to 7 days; penetrating injury 1-7 days, vascularisation in lower parts of cornea at 7 days; -iris: no effect; -conjuctiva; slight redness (day 3), slight swelling (day 3).slight discharge (day3)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: generalized area of slight cloudiness 1hr- 3 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: redness mild 1 hr-3 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: swelling: mild 1-4 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: generalised  slight cloudiness up to 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: slight redness (day 3)
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: slight swelling  (day 3)
Irritant / corrosive response data:
animal 1: not washed-----effects fully reversible within 7 days
cornea: generalized area of slight cloudiness 1hr- 3 days; -----iris: no effects; -----conjunctivae: (1) redness mild 1 hr-3 days, (2) swelling: mild 1-4 hrs, (3) discharge: copious 1-4 hrs
Other effects:
animal 1: not washed-----effects fully reversible within 7 days
cornea: generalized area of slight cloudiness 1hr- 3 days; -----iris: no effects; -----conjunctivae: (1) redness mild 1 hr-3 days, (2) swelling: mild 1-4 hrs, (3) discharge: copious 1-4 hrs

animal 1: not washed-----effects fully reversible within 4 days

cornea: generalized area of slight cloudiness 1hr- 3 days; -----iris: no effects; -----conjunctivae: (1) redness mild 1 hr-3 days, (2) swelling: mild 1-4 hrs, (3) discharge: copious 1-4 hrs

animal 2: eye washed: -cornea: generalised  slight cloudiness up to 7 days;  penetrating injury 1-7 days, vascularisation in lower parts of cornea at 7 days; -iris: no effect; -conjuctiva; slight redness (day 3), slight swelling  (day 3), slight discharge (day3).

Thus, the test material produced temporary slight to mild occular effects with transient copious discharge

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Executive summary:

The test material produced temporary mild to slight occular effects with transient copious discharge: As these effects were fully reversible within the observation period of 14 days the test material was evaluated to be slightly irritating to the eyes of rabbits (DuPont De Nemours 1980), with observations not relevant for classification

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin corrosion/irritation:

Undiluted m-toluidine produced slight irritational skin effects when tested on shaved intact skin of rabbits. Due to the short observation time of 48 hours, these effects can be observed throughout the entire observation period (DuPont De Nemours 1980) but are not relevant for classification Therefore there is no need for classification.

Eye irritation:

The test material produced temporary slight to mild oclular effects with copious discharge: As these effects were fully reversible within the observation period of 14 days the test material was evaluated to be slightly irritating to the eyes of rabbits (DuPont De Nemours 1980), with observations not relevant for classification.


Justification for selection of skin irritation / corrosion endpoint:
the available relvat study for skin irritation provides all necessary data to evaluate this endpoint and is therefore evaluated with Klimisch score: 2

Justification for selection of eye irritation endpoint:
This is the only relevant study because it is equal to the requirements of today and therefore evaluated with Klimisch score 2

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.