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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted according to GLP. However, purity of test article is unknown.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
Semi-occlusive dressing is recommended by guideline. However, occlusive dressing was used (worst case).
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
401-540-3
EC Name:
-
Cas Number:
84632-65-5
Molecular formula:
C18H10Cl2N2O2
IUPAC Name:
3,6-bis(4-chlorophenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Strain as stated in the report: KFM-Han. Wistar (outbred, SPF)
- Source: Kleintierfarm Madoerin AG CH-4414 Fuellinsdorf / Switzerland
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 228 - 256 g (males), 197 - 211 g (females)
- Housing: individually in Makrolon type-2 cages
- Diet (ad libitum): pelleted standar Kliba 343, rat maintenance diet
- Water (ad libitum): tap water
- Acclimation period: 1 week

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on dermal exposure:
TEST SITE
- Area of exposure: back of animals
- % coverage: 10 % of total body surface
- Type of wrap: Occlusive dressing fixed with elastic adhesive bandage.

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

TEST MATERIAL
- Application Volume/kg bw: 4 ml, corresponding to 2000 mg/kg bw.
- For solids, paste formed: Yes, test article was homogenised in PEG 400.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 animals (5 males, 5 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations for mortality and clinical symptoms: 4-times at day one, afterwards daily.
- Frequency of weighing: Weights of animals were assessed on day 1, 8 and 15.
- Necropsy of survivors performed: Yes, all animals were sacrificed and subjected to gross pathology.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: None of the treated animals died.
Mortality:
No animal died.
Clinical signs:
other: After treatment a reddish skin discoloration was observed in all rats during the observation period. No other signs of local or systemic toxicity were observed.
Gross pathology:
No macroscopic findings were observed at necropsy.

Any other information on results incl. tables

Table 1: Mean body weights in grams (Dose level: 2000 mg/kg bw)

Test day

1*

8

15

 

 

 

 

Male

240 +/- 10

255 +/- 11

275 +/- 14

Female

206 +/- 5.4

211 +/- 8

219 +/- 8.7

body weights on day 1 were assessed before application of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a GLP-study according to OECD TG 402 using the limit test dose of 2000 mg/kg bw, the dermal LD50 of the substance was determined to be > 2000 mg/kg bw in both females and males.
Executive summary:

The acute dermal toxicity of the substance was inevstigated in a GLP-compliant staudy according to OECD Test Guideline 402 (version 1981). Suspended in polyethylene glycol, 2000 mg/kg bw of the substance were occlusively applied to the skin of 5 male and 5 female Wistar rats for 24 hours. The rats were observed for clinical signs, body weight change and mortality for 15 days. After sacrifice, the rats were subjected to gross pathology. Besides some reddish skin discoloration, no effects of the substance, especially mortality and on body weight, were observed. Therefore, the LD50 was > 2000 mg/kg bw for both sexes.