3-chloroaniline

Endpoint summary

Description of key information

The substance 3-chloroaniline was found to be irritating in skin and eye category.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Justification for type of information:

QSAR prediction: migrated from IUCLID 5.6

Principles of method if other than guideline:

The prediction is done using QSAR Toolbox version 2.3

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Irritation parameter:

other: Primary irritation index (PII)

Basis:

mean

Score:

1.74

Reversibility:

no data

Remarks on result:

other: Slightly irritating to the skin of rabbit.

The prediction was based on dataset comprised from the following descriptors: "Primary Irritation Index"
Estimation method: Taking average value from the 6 nearest neighbours
Domain logical expression:Result: In Domain

(("a" and "b" ) and ("c" and "d" ) )

Domain logical expression index: "a"

Similarity boundary:Target: c1(Cl)cc(N)ccc1
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Similarity boundary:Target: c1(Cl)cc(N)ccc1
Threshold=60%,
Dice(Atom pairs)

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of log Kow which is >= 1.12

Domain logical expression index: "d"

Parametric boundary:The target chemical should have a value of log Kow which is <= 2.19

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

By primary irritation index (PII) from QSAR, skin irritation score of 3-chloroaniline was estimated to be 1.74.Based on this score it infers that the substance 3-chloroaniline was found to be slightly irritating to the skin of rabbit.

Executive summary:

By primary irritation index (PII) from QSAR, skin irritation score of 3-chloroaniline was estimated to be 1.74.Based on this score it infers that the substance 3-chloroaniline was found to be slightly irritating to the skin of rabbit.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Vehicle:

not specified

Controls:

not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Reversibility:

fully reversible

Remarks on result:

other: 3-Chloroaniline caused slight to moderate irritation to the conjunctiva but this was completely reversible; 3-Chloroaniline was therefore judged to be slightly to moderately irritating to the eyes.

Irritation parameter:

cornea opacity score

Basis:

mean

Reversibility:

fully reversible

Remarks on result:

other: 3-Chloroaniline caused slight to moderate irritation to the cornea but this was completely reversible; 3-Chloroaniline was therefore judged to be slightly to moderately irritating to the eyes.

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a standardized test on rabbits' eyes (according to OECD guideline 405), 3-Chloroaniline caused slight to moderate irritation to the conjunctiva and cornea but this was completely reversible; 3-Chloroaniline was therefore judged to be slightly to moderately irritating to the eyes.

Executive summary:

In a standardized test on rabbits' eyes (according to OECD guideline 405), 3-Chloroaniline caused slight to moderate irritation to the conjunctiva and cornea but this was completely reversible; 3-Chloroaniline was therefore judged to be slightly to moderately irritating to the eyes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

No.of various studies were reviewed for skin irritation with Klimish rating 2 & 4 for the target as well as the read across substances for CAS: 108-42-9 considering the weight of evidence approach.

The results for target substance as well as analogues are summarized as follows

 

Sr. No	Irritation Parameter	Species	Interpretation of results	Conclusions	Sources
1	Primary irritation index (PII)	Rabbit	Slightly irritating	By primary irritation index (PII) from QSAR, skin irritation score of 3-chloroaniline was estimated to be 1.74.Based on this score it infers that the substance 3-chloroaniline was found to be slightly irritating to the skin of rabbit.	Predicted data for CAS:108-42-9
2	Erythema and edema score	-	Mildly Irritating	Skin irritation tests performed in accordance with OECD Test Guideline: "Mild erythema and edema were induced at 24 and 48 hours, with recovery observed by 72 hours." The substance 3-chloroaniline is thus considered "mildly irritating."	Data from study report for CAS : 108-42-9
3	Overall irritation score	Rabbit	Mildly Irritating	500 mg of m-toluidine applied to the skin of rabbits for 24 hrs, resulted in a mild irritation effect.	Data from publication for RA CAS : 108-44-1

 

Based on the above results it can be concluded that substance CAS: 108-42-9 is expected to show the similar toxicological effect based on the effects observed on the other category members. Thus it is concluded that the substance 3-chloroaniline was found to be irritating (slight-mild) to the skin of rabbit. Based on these results it can be concluded that 3-chloroaniline is classified as a skin irritant in category 2 as per the CLP regulation.

 

Eye irritation

Based on various studies that were reviewed for eye irritation for the target as well as the read across substances for CAS: 108-42-9 considering the weight of evidence approach.

The results for target substance as well as analogues are summarized as follows

 

Sr.No	Irritation Parameter	Species	Interpretation of results	Conclusions	Sources
1	Conjunctivae score and cornea score	Rabbit	Slightly to moderately irritating	In a standardized test on rabbits' eyes (according to OECD guideline 405), 3-Chloroaniline caused slight to moderate irritation to the conjunctiva and cornea but this was completely reversible; 3-Chloroaniline was therefore judged to be slightly to moderately irritating to the eyes.	Data from IFA GESTIS database for CAS :108-42-9
2	Cornea score	-	Irritating	Based on the description in CERI Hazard Data 2000-35 (2001) of eye irritation tests performed in accordance with OECD Test Guideline: "Mild corneal lesion (irreversible) and moderate corneal irritation were observed." The substance 3-chloroaniline is thus considered "irritating" .	Data from study report for CAS:108-42-9
3	Overall irritation score	Rabbit	Moderately irritating	20 mg of m-toluidine applied to the eyes of rabbits for 24 hrs, resulted in a moderate irritation effect.	Data from publication for RA CAS : 108-44-1

 

Based on the above results it can be concluded that substance CAS: 108-42-9 is expected to show the similar toxicological effect based on the effects observed on the other category members. Thus it is concluded that the substance 3-chloroaniline was found to be irritating (slight to moderate) to the eyes of rabbit. Based on these results it can be concluded that 3-chloroaniline is classified as an eye irritant in category 2 as per the criteria of CLP regulation.

Justification for selection of skin irritation / corrosion endpoint:

By primary irritation index (PII) from QSAR, skin irritation score of 3-chloroaniline was estimated to be 1.74.Based on this score it infers that the substance 3-chloroaniline was found to be slightly irritating to the skin of rabbit.

Justification for selection of eye irritation endpoint:

In a standardized test on rabbits' eyes (according to OECD guideline 405), 3-Chloroaniline caused slight to moderate irritation to the conjunctiva and cornea but this was completely reversible; 3-Chloroaniline was therefore judged to be slightly to moderately irritating to the eyes.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

The available studies indicate that the substance 3-chloroaniline is classified as a skin and eye irritant in category 2 according to CLP regulation.