1,4-Benzenedisulfonic acid, 2,2'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-[3-substituted-heteroalkyl]-1,3,5-triazine-4,2-diyl]imino]]bis-, sodium salt

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP guideline study, tested with the source substance CAS 16470-24-9. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wblferstrasse 4, CH-4414 Fullinsdorf
- Age at study initiation: 10 weeks (males), 12 weeks (females)
- Weight at study initiation: 225 - 247 g (males), 200 - 222 g (females)
- Housing: individually in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet: pelleted standard Kliba 343, Batches 77/90 and 78/90 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst); ad libitum
- Water: community tap water from Itingen; ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10 - 15 air changes per hr
- Photoperiod: 12 / 12 hrs dark / hrs light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: backs of the animals
- Preparation: clipping 24 h before application
- % coverage: 10% of the total body surface

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 4 mL
- Concentration: 100%
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations four times during test Day 1, and daily during Days 2 - 15; weighing on test Days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology

Statistics:

The LOGIT-Model could not be applied to the observed rate of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality.

Clinical signs:

No systemic signs were observed in the animals during the entire observation period.
Skin observations: males/females: scales (back) (10/10); general erythema (back) (3/10); males: erythema focal (back) (3/5). All animals had recovered from the local signs after 7 observation days.

Body weight:

Mean body weight (g): Days 1, 8, 15
- males: 236.2, 265.2, 294.8
- females: 207.3, 214.0, 217.8

Gross pathology:

No findings noted.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Executive summary:

Method

Upon an acute oral single administration (2000 mg/kg bw) and a 15 day post-treatment observation period, the dermal LD50 was determined for the test substance, according to the OECD Guideline 402.

Results

LD50 > 2000 mg/kg bw

No deaths accorred and no systemic signs were observed in the animals during the entire observation period. Skin reactions are all recovered after 7 observation days.