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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: Comparable to guideline study OECD 402 (BASF method).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
According to BASF-internal standard. Young adult laboratory rats in groups of 5 to 10 rats per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle occlusive on the skin. Group-wise documentation of clinical signs was performed over the 7 to 14 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Kerobit BPD, N,N'-Di-sek .-butyl-p-phenylendiamin
- Physical state: liquid, colorless
- Analytical purity: 98%
- Lot/batch No.: 82/175
- Stability under test conditions: stable for study period
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: 12 weeks
- Weight at study initiation: 200 - 300 g
- Housing: single housing in V-II-A-Stahl cages, Type DK-III during exposure, if no skin lesions were identified group housing
- Diet: SSNIFF R, Fa. SSNIFF, Versuchstierdiaeten, Soest
- Water: tap water, ad libitum
- Acclimation period: approximately 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % aqueous
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm2, dorsal and dorsolateral areas of the trunk
- Type of wrap if used: inert foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration (if solution): 10% (g/V)
- Amount(s) applied (volume or weight with unit): 3.2, 5.6, 8.3 and 12.1 ml/kg bw
Duration of exposure:
24 hours
Doses:
316, 562, 825 and 1210 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: observations: several times on the day of application and at least once per working day thereafter, check of moribund and dead animals twice each working day and once on weekends and on public holidays, skin observations: 30 - 60 minutes after removal of the occlusive bandage and at least once during the observation period, body weight: before application and on days 4, 7 and 13 following application - Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
756 mg/kg bw
95% CL:
623 - 903
Mortality:
Male animals: 316 mg/kg bw: no deaths after 14 days; 562 mg/kg bw: 2/5 after 14 days; 825 mg/kg bw: 4/5 after 14 days; 1210 mg/kg bw: 5/5 after 14 days Female animals: 316 and 562 mg/kg bw: no deaths after 14 days; 825 mg/kg bw: 1/5 after 14 days; 1210 mg/kg bw: 5/5 after 14 days
Clinical signs:
Dyspnea, apathy, staggering, trembling (males only), poor general state (all symptoms were observed on day 1)
Local signs: substance residues (day 1), deep necrosis (from day 7 to day 13), edema (from day 1 to day 13)
Body weight:
Mean body weight male animals: 259 g at study start, 294 g after 13 days
Mean body weight female animals: 212 g at study start, 228 g after 13 days
Gross pathology:
Animals that died: congestive hyperpemia; liver: partly clay-coloured peripher markings of lobules; application area: colloidal edema of the subcutis.
Sacrificed animals: nothing abnormal detected; application area: extensive necrosis, status: healing (demarcation).

Any other information on results incl. tables

Table 1. Table for acute dermal toxicity. 

Dose
[mg/kg bw]

Toxicological results*

Duration of clinical signs

Local skin effects

Time of death

Mortality (%)

 

Males

316

0/5

Day 1

substance residues on day 1,

deep necrosis (day 7 – day 13)

edema (day 1 day 13)

---

0

562

2/5

Day 1

substance residues on day 1,

deep necrosis (day 7 – day 13)

edema (day 1 day 13)

Day 1

40

825

4/5

Day 1

substance residues on day 1,

deep necrosis (day 7 – day 13)

edema (day 1 day 13)

Day 1 – Day 2

80

1210

5/5

Day 1

---

Day 1

100

 

Females

316

0/5

Day 1

substance residues on day 1,

deep necrosis (day 7 – day 13)

edema (day 1 day 13)

---

0

562

0/5

Day 1

substance residues on day 1,

deep necrosis (day 7 – day 13)

edema (day 1 day 13)

---

0

825

1/5

Day 1

substance residues on day 1,

deep necrosis (day 7 – day 13)

edema (day 1 day 13)

Day 1

20

1210

5/5

Day 1

---

Day 1

100

 

LD50 = 756 mg/kg bw

* first number = number of dead animals                                 

  second number = number of animals used                               

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD:Xn, R21
CLP: Cat. 3, H311