Registration Dossier

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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
24 hour exposure to intact or abraded skin.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Davidson's Hill Farm, Jamesburg, New Jersey
- Age at study initiation: no data
- Weight at study initiation: 2040-2815g
- Fasting period before study: no data
- Housing: individually in elevated metal cages
- Diet: Purina Lab Rabbit Chow ad libitum)
- Water: ad libitum
- Acclimation period: 1 week

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
200, 2000 and 5000
No. of animals per sex per dose:
4

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
One female from 5000 mg/kg group was found dead on day 7
Clinical signs:
The only systemic clinical effects reported were slight to marked anorexia in all groups and eye discharge in a single mid-dose male. Local effects including erythema, oedema, blanching and epidermal scaling were reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study TBEP has a low acute dermal toxicity when tested on the rabbit.
Executive summary:

The test article, MCTR-16 -79 (tris(2-butoxyethyl) phosphate) was evaluated for acute dermal toxicity in groups of male and female New Zealand White rabbits. Half of the animals in each test group (4M + 4F) had an area of exposed skin (for subsequent dosing) abraded with minor incisions sufficiently deep to penetrate the stratum corneum but not deep enough to disturb the dermis or produce bleeding. The skin of the remaining rabbits was left intact.  The test substance was left in contact with the skin for 24-h under a non-absorbent binder. Dermal effects recorded following exposure were scored on days 1, 3, 7, 10 and 14 according to Draize. Surviving animals were killed on day 14 and a post-mortem examination was conducted.

One female animal of the 5000 mg/kg group was found dead on day 7. The only systemic clinical effects reported were slight to marked anorexia in all groups and eye discharge in a single mid-dose male. Local effects including erythema, oedema, blanching and epidermal scaling were reported.

According to the results of this study, the dermal LD50 is > 5000 mg/kg.