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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2017-08-10 to 2017-11-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
See chapter 13 for support for read-across within the category of Alkyl Naphthalene Sulfonates (ANS).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
version 2015
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany

Test material

Constituent 1
Chemical structure
Reference substance name:
Naphthalenesulfonic acid, bis(1-methylethyl)-, Me derivs., sodium salts
EC Number:
272-715-8
EC Name:
Naphthalenesulfonic acid, bis(1-methylethyl)-, Me derivs., sodium salts
Cas Number:
68909-82-0
Molecular formula:
UVCB substance
IUPAC Name:
Aromatic hydrocarbons, C10-13, reaction products with isopropylalcohol, sulphonated, sodium salts
Test material form:
solid: granular
Details on test material:
Name: Naphthalenesulfonic acid, bis(1-methylethyl)-, methyl derivs., sodium salt
Product: MORWET IP Powder
Chemical Name: Naphthalenesulfonic acid, bis(1-methylethyl)-, methyl derivs., sodium salt
CAS No.: 68909-82-0
Batch No.: 1452486
Physical State: solid, powder
Colour: tan
pH: 7.5 to 10 in 5 % solution
Active Components: UVCB substance with 100% purity
Average molecular weight: 346 g/mol (range from 213-474 g/mol)
Purity: 100 %
Storage Conditions: room temperature
Expiry Date: 07 June 2021
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Housing and Feeding Conditions:
- Semi barrier in an air-conditioned room
- Temperature: 18 +/- 3 °C (recommendations of TVT, GV-SOLAS)
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Housed in ABS-plastic or Noryl rabbit cages, floor 4200 cm2
- Adequate acclimatisation period (at least 5 days) under laboratory conditions



Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Dose Level
A dose of 0.5 g of the test item was applied to each test site.
Duration of treatment / exposure:
Exposure Period
The test item was held in contact with the skin throughout a 4-hour period.
At the end of the exposure period, the residual test item was removed with sterile water.
Observation period:
Observation Period
Due to the persistent lesions 72 hours after the patch removal, the observation period was extended in order to evaluate the reversibility or irreversibility of the lesions. Therefore, animal no. 1 was observed for 8 days, animal no. 2 and 3 were observed for 14 days.
Number of animals:
3
Details on study design:
Clinical Observation
The animals were examined for signs of erythema and oedema 1 hour after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema 24, 48 and 72 hours after the patch removal. Dermal irritation was scored and recorded according to the grades in the table below. Any other signs such as hyperplasia, scaling, discolouration, fissures and scabs or any systemic effects were also recorded.
For the initial test in one animal, the test site was also examined immediately after the patch had been removed.

Evaluation of Results
Individual reactions for each animal were recorded according to the scoring system described in the table below at each time of observation.
Nature, severity and duration of clinical observations were described.
The body weight changes were summarised in a tabular form.

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
4
Reversibility:
not fully reversible within: 14 days. fully reversible within up to 8 days in animal no. 1 but not reversible in animal no. 2 and 3 both showing a persistent grade 1 erythema.
Irritant / corrosive response data:
Initial test in animal no. 1: The examination of the test site immediately after the patch removal revealed erythema grade 1.
The subsequent clinical observations causes skin irritation (erythema grade 1 and 2, oedema grade 1) but no corrosive effects in animal no. 1, 2 and 3. These signs of irritation were not reversible within the observation period of 14 days in animal no. 2 and 3.
Other effects:
No mortalities were observed. No adverse changes apart from the reactions described above were observed at the skin sites.
There were no significant body weight changes during the observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of the present study, the single dermal application of the test item Naphthalenesulfonic acid, bis(1-methylethyl)-, methyl derivs., sodium salt to three rabbits at a dose of 0.5 g causes skin irritation but no corrosive effects which were fully reversible within up to 8 days in animal no. 1 but not reversible in animal no. 2 and 3.
Neither mortalities nor significant clinical signs of toxicity were observed.

Executive summary:

Summary Results

Species/strain:                                       New Zealand White Rabbits Crl: KBL (NZW)

Number of animals:                              3

Duration of exposure:                           4 hours

Amount of substance:                          0.5 g per test site

Vehicle (moistening):                           aqua ad injectionem

First time of effects:                              animal no. 1: immediately after patch removal erythema grade 1

animal no. 2 and no. 3: 1 hour after patch removal erythema grade 1

Last time of effects:                              animal no. 1: 7 days after patch removal erythema grade 1

animal no. 2 and no. 3: 14 days after patch removal erythema grade 1

Reversibility of the observed effects:  animal no. 1: the changes were fully reversible within 8 days after patch removal.

animal no. 2 and 3: the changes were not reversible within the observation period.

Method: OECD 404, EC 440/2008, Method B.4, OPPTS 870.2500

Average Irritation Scores – (24, 48, 72-hour reading) – and Total Mean Value

Mean Value Irritation Scores
Animal No. Mean 24 – 72 hours
Erythema Oedema
1 2 0.33
2 2 1
3 1.67 0
Total Mean Value 1.9 0.44

Conclusion

Under the conditions of the present study, the single dermal application of the test itemNaphthalenesulfonic acid, bis(1-methylethyl)-, methyl derivs., sodium saltto three rabbits at a dose of 0.5 g causes skin irritation but no corrosive effects which were fully reversible within up to 8 days in animal no. 1 but not reversible in animal no. 2 and 3.

Neither mortalities nor significant clinical signs of toxicity were observed.