Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted according to internationally accepted testing guidelines and performed according to GLP. The tested substance is the analogous tetrasulphonated part of the Stilbene Fluorescent Whitening Agent category, group 3. It has therefore siilar organic functional groups, but two more sulphonated groups, therefore a higher salification degree. Skin adsorption was evaluated and calculated for all members of the category (see Category Justification Report, Section 13). As it can be noted, the influence of the variability in functional group is very low, more related to the variability in the polarity of the substance than on potential reactivity that can arise a concern. From a metabolic point of view an estimation with OECD Toolbox of the dermal metabolism has been performed in order to verify if breakdown products could be formed. Results are negative for all members. Oral acute toxicity is comparable for the two substances (CAS 16470-24-9 and 13863-3-5), with very high estimated LD50. The two substances are expected to have a similar behaviour regarding dermal acute toxicity, as well as all the other members of the Stilbene Fluorescent Whitening Agents category.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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 according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kg bw
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.