Registration Dossier

Administrative data

Description of key information

The substance 4-Chlororesorcinol is found to be irritating to skin and eye.

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data is from review article.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.5 g (0.5 g, moistened with 60 ml Milli-U water)
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours, and 7 and 14 days after exposure.
Number of animals:
3 male rabbit
Details on study design:
TEST SITE
- Area of exposure: Clipped skin
- Type of wrap if used: semi-occlusive dressing
SCORING SYSTEM: erythema, oedema, full thickness destruction of the skin or scar tissue
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1-14 days
Reversibility:
no data
Remarks on result:
other: Slight, well defined or moderate to severe erythema and slight or moderate oedema
Irritant / corrosive response data:
Four hours exposure to 0.5 g of4-Chlororesorcinol resulted in slight, well defined or moderate to severe erythema and slight or moderate
oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 14 days after exposure in one animal, but remained present up to termination in the other animals.
Other effects:
No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the
skin had occurred by dermal application of A12 to the intact rabbit skin. Brown staining of the treated skin by the test substance was observed on all animals during the observation period, which did not hamper
the scoring of the skin reaction
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
4-Chlororesorcinol is found to be irritating to the skin of rabbit when treated at 0.5g of concentration for 4 hrs.
Executive summary:

A skin irritation study for 4-Chlororesorcinol was observed on New Zealand White strain rabbit. No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the skin had occurred by dermal application of 4-Chlororesorcinol to the intact rabbit skin.

Brown staining of the treated skin by the test substance was observed on all animals during the observation period, which did not hamper the scoring of the skin reaction.

Four hours exposure to 0.5 g of 4-Chlororesorcinol resulted in very slight, well defined or moderate to severe erythema and slight or moderate oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 14 days after exposure in one animal, but remained present up to termination in the other animals.

Thus from overall observation of the study it can be concluded that 4-Chlororesorcinol is likely to be irritating to the skin.

 

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)
Rationale for reliability incl. deficiencies:
other: Data is from review article.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Sex: male
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
56.1 mg neat test substance (a volume of approximately 0.1 ml)
Observation period (in vivo):
1 and 24 hours
Number of animals or in vitro replicates:
1 male rabbit
Details on study design:
TEST SITE
- Area of exposure: Corneal area
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Corneal and conjunctival parameters
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: corneal injury consisted of opacity (maximum grade 4) and epithelial damage (100% of the corneal area).
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: The irritation of the conjunctivae consisted of redness (also of the outside of the eyelids), chemosis and discharge.
Irritant / corrosive response data:
In addition, grey-white discolouration (a sign of necrosis) of the eyelids and nictitating membrane was noted during the observation period.
Due to the corneal damage, iridial irritation could not be assessed.
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
4-Chlororesorcinol is found to be irritating to New Zealand White strain rabbit eye when treated at 56.1 mg neat concentration.
Executive summary:

Eye irritation study for 4-Chlororesorcinol was observed on New Zealand White strain rabbit. A single sample of 56.1 mg of 4-Chlororesorcinol (a volume of approximately 0.1 ml) was instilled into an eye of one rabbit.

Observations were made 1 and 24 hours after instillation. The corneal injury consisted of opacity (maximum grade 4) and epithelial damage (100% of the corneal area).

The irritation of the conjunctivae consisted of redness (also of the outside of the eyelids), chemosis and discharge. In addition, grey-white discoloration (a sign of necrosis) of the eyelids and nictitating membrane was noted during the observation period. Due to the corneal damage, iridial irritation could not be assessed. Based on the severity of the eye lesions, the animal was sacrificed for ethical reasons after the 24 hours observation.

Therefore, it can be concluded that 4-Chlororesorcinol is likely to be irritating to New Zealand White strain rabbit eye.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Weight of evidence studies were reviewed for skin irritation from reliable sources having Klimish rating 2 and 4.

 

The summary of the results are presented below:

Sr.No

Irritation Parameter

Species

Interpretation of results

Conclusions

Sources

1

Overall irritation score

Rabbit

Irritating

4-Chlororesorcinol is found to be irritating to the skin of rabbit when treated at 0.5g of concentration for 4 hrs.

Data from Scientific Committee on Consumer Safety (SCCS) - report

2

Primary dermal irritation index (PDII)

Rabbit

Not irritating

4-Chlororesorcinol is found to be non –irritant on New Zealand White strain rabbit skin when tested 2.5 % (w/v) concentration for 72 h.

Data from Publication

 3  Primary dermal irritation index  Rabbit  moderatly irritating 4-chlororesorcinol, it was estimated that the dermal irritation index is 3.6 tested on rabbits. Based on this value, it can be concluded that 4-chlororesorcinol is mooderatly irritating to skin. Predicted data

 

Based on the weight of evidence available, it is concluded that the substance 4-Chlororesorcinol is likely to be irritating to the skin

of rabbit and thus can be classified as skin irri 2 category as per the criteria of CLP regulation.

 

Eye irritation

The summary of the results are presented below:

Sr.No

Irritation Parameter

Species

Interpretation of results

Conclusions

Sources

1

Corneal and Conjunctivae score

Rabbit

Irritating

4-Chlororesorcinol is found to be irritating to New Zealand White strain rabbit eye.

Data from Scientific Committee on Consumer Safety (SCCS) - report

 

Based on the above data, it is concluded that the substance 4-Chlororesorcinol is likely to be irritating to th

eye of rabbit.

Justification for selection of skin irritation / corrosion endpoint:
4-Chlororesorcinol is found to be irritating to the skin of rabbit when treated at 0.5g of concentration for 4 hrs.

Justification for selection of eye irritation endpoint:
4-Chlororesorcinol is found to be irritating to New Zealand White strain rabbit eye when treated at 56.1 mg neat concentration.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

The available data indicates that the substance 4-Chlororesorcinol is likely to classify as a skin and eye irritant according to criteria of the CLP regulation.