Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets National standrds method with acceptable restrictions.

Data source

Reference
Reference Type:
other: 1,2,3-trinitroglycerin (TNG) CAS RN. 55-63-0 Summary of SIDS results
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Rats were not weighed seven days post-treatment.
GLP compliance:
yes
Test type:
other: Single dose (acute

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- The test material was neat TNG, isolated from an ethanol solution immediately prior to testing. The ethanol solution was from commercial production (usually 99+ percent pure). However, sponsor did not supply an analysis.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Ace Animal Supply- Age at study initiation: young adults- Weight at study initiation: Male average pre-dose weight was 263.6 ± 14.2 (S.D.) gm, female average pre-dose weight was 221.5 ± 14.5 (S.D.)gm.

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Duration of exposure:
All animals were dosed in three equal volume applications separated by a 30 minute absorption period.
Doses:
9,560mg/kg
No. of animals per sex per dose:
10 females and 10 males

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 560 mg/kg bw
Based on:
test mat.
Clinical signs:
Clinical signs Mounth wet&brown, Body surface wet and Body surface appear oily&umkempt. had essentially equal incidences in males and females. However, signs Anogenital area wet, Skin bluish, Anogenital area brown and Chromodacryorrhea were noted more frequently in females than males. C was reported more frequently in males than females, but the incidences were each so small, that it is doubtful they were significantly different. These sex differences in incidence probably have no significance for humans, medicinally or occupationally.
Gross pathology:
All animals were normal except Males 1 & 10 who had unilateral moderate or slight hydronephrosis. Hydronephrosis also was observed in 4 of 5 malerats from the same supplier in an acute oral study in rats from the same supplier in the same year. It also was not seen in females in the latter study.
Other findings:
TARGET ORGAN(S)None could be identified with the possible exception of the kidney. However, in the Acute Oral study in this strain of rats from the same supplier, neither the incidence, the severity, nor its unilateral/bilateral occurrence were dose-related, suggesting that it is not test-material related in these rats. Also, in this acute dermal application study, as well as the acute oral study, it occurred only in males. This also suggests it is not test-material related.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
TNG does not appear to be as toxic when absorbed through rat skin as when administered orally. This is evidenced by the lack of dose-related gross effects on internal organs seen following intubation at oral doses that were only 17 and 50% of the dose applied to the rat's skin in this skin absorption study.