Reaction products of aniline-4-sulfonic acid diazo with formaldehyde and resorcinol, sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From the 5th to the 8th of January, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From the 5th to the 8th of January, 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Justification for Read Across is detailed in the section summary and it is further detailed in the report attached to the IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
As required by the Dutch Act on Animal Experimentation, the study protocol was reviewed and agreed by the Article 14-functionary and the EthicalCommittee of NOTOX.
Species: Albino Rabbit, New Zealand White, (SPF-Quality)
Source: Charles River Nederland, the Netherlands
Age and body weight: at least 6 weeks old and body weights less than 3.5 kg
Identification: earmark
ENVIRONMENTAL CONDITIONS
Conditions: air-conditioned room with approximately 15 air changes per hour
Temperature: 21°C
Relative humidity of 50%.
Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity.
Lighting: 12 hours artificial fluorescent light and 12 hours dark per day.
Accomodation: Individually housed in labelled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
Acclimatisation period: at least 5 days before start of treatment under laboratory conditions.
Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 gram per day. In addition, hay (BMI, Helmond, The Netherlands) was provided once a week.
Certificates of analysis were examined and then retained in the NOTOX archives.
Free access to tap-water diluted with decalcified water.
Certificates of quarterly analysis were examined and then retained in the NOTOX archives.

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g in water

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after the removal of the dressings and the test substance

Number of animals:

3 animals of one sex

Details on study design:

Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm).
Whenever considered necessary the treated skin areas were re- clipped at least 3 hours before the observations, to facilitate scoring.
A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.
Each animal was treated by dermal application of 0.5 gram of the moistened test substance to the skin of one flank, using a metalline patch of 2x3 cm.The patch was mounted on Micropore tape , which was wrapped around the abdomen and secured with Cohan elastic bandage.
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water.
OBSERVATIONS
Mortality/Viability: twice daily
Toxicity: once a day
Body weights: day of the treatment
Irritation: the skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.
Adjacent areas of the untreated skin of each animal served as controls.
The irritation was assessed according to the numerical scoring system.
No hystophatology was performed.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: brown staining of the skin

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: brown staining of the skin

Irritant / corrosive response data:

Irritation
No skin irritation was caused by 4 hours of exposure
Corrosion
There was no evidence of a corrosive effect on the skin.

Other effects:

Colouration
Brown remnants of the test substance were present on the skin from day 1 onwards untii 48 hours after exposure.
Toxicity/Mortaiity
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Interpretation of results:

other: no skin irritant

Remarks:

Classification criteria according to the CLP Regulation 1272/2008 and its amendments

Conclusions:

No skin irritation was caused by 4 hours of exposure.
Brown remnants, caused by the test substance, was noted during the observation period.
 

Executive summary:

The skin irritation/corrosion test was performed on a similar substance 01 (read-across from supporting substance -structural analogue or surrogate, according to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion).

Three rabbits were exposed to 0.5 gram of the similar substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were madeat 1, 24, 48 and 72 hours. No skin irritation was caused by 4 hours of exposure to the similar subtance. Brown remnants of the test substance were present on the skin from day 1 onwards until 48 hours after exposure.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Acid brown 188:1

IUPAC Name:

Acid brown 188:1

Test material form:

solid: particulate/powder

Details on test material:

Description Brown powder
Test substance storage At room temperature in the dark
Stability under storage conditions Not indicated
Expiry date 29 August 2002 (allocated by NOTOX, 1 year after)

Test animals

Details on test animals or test system and environmental conditions:

TEST ANIMALS
As required by the Dutch Act on Animal Experimentation, the study protocol was reviewed and agreed by the Article 14-functionary and the EthicalCommittee of NOTOX.
Species: Albino Rabbit, New Zealand White, (SPF-Quality)
Source: Charles River Nederland, the Netherlands
Age and body weight: at least 6 weeks old and body weights less than 3.5 kg
Identification: earmark
ENVIRONMENTAL CONDITIONS
Conditions: air-conditioned room with approximately 15 air changes per hour
Temperature: 21°C
Relative humidity of 50%.
Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity.
Lighting: 12 hours artificial fluorescent light and 12 hours dark per day.
Accomodation: Individually housed in labelled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
Acclimatisation period: at least 5 days before start of treatment under laboratory conditions.
Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 gram per day. In addition, hay (BMI, Helmond, The Netherlands) was provided once a week.
Certificates of analysis were examined and then retained in the NOTOX archives.
Free access to tap-water diluted with decalcified water.
Certificates of quarterly analysis were examined and then retained in the NOTOX archives.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g in water

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after the removal of the dressings and the test substance

Number of animals:

3 animals of one sex

Details on study design:

Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm).
Whenever considered necessary the treated skin areas were re- clipped at least 3 hours before the observations, to facilitate scoring.
A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.
Each animal was treated by dermal application of 0.5 gram of the moistened test substance to the skin of one flank, using a metalline patch of 2x3 cm.The patch was mounted on Micropore tape , which was wrapped around the abdomen and secured with Cohan elastic bandage.
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water.
OBSERVATIONS
Mortality/Viability: twice daily
Toxicity: once a day
Body weights: day of the treatment
Irritation: the skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.
Adjacent areas of the untreated skin of each animal served as controls.
The irritation was assessed according to the numerical scoring system.
No hystophatology was performed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: brown staining of the skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: brown staining of the skin

Irritant / corrosive response data:

Irritation
No skin irritation was caused by 4 hours of exposure
Corrosion
There was no evidence of a corrosive effect on the skin.

Other effects:

Colouration
Brown remnants of the test substance were present on the skin from day 1 onwards untii 48 hours after exposure.
Toxicity/Mortaiity
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

other: no skin irritant

Remarks:

Classification criteria according to the CLP Regulation 1272/2008 and its amendments

Conclusions:

No skin irritation was caused by 4 hours of exposure.
Brown remnants, caused by the test substance, was noted during the observation period.
 

Executive summary:

The skin irritation/corrosion test was performed according to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion).

Three rabbits were exposed to 0.5 gram of the similar substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were madeat 1, 24, 48 and 72 hours. No skin irritation was caused by 4 hours of exposure to the similar subtance. Brown remnants of the test substance were present on the skin from day 1 onwards until 48 hours after exposure.