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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June- July 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: in accordance with guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chloro-α,α,α-trifluoro-3-nitrotoluene
EC Number:
204-451-6
EC Name:
4-chloro-α,α,α-trifluoro-3-nitrotoluene
Cas Number:
121-17-5
Molecular formula:
C7H3ClF3NO2
IUPAC Name:
1-chloro-2-nitro-4-(trifluoromethyl)benzene
Details on test material:
- Name of test material (as cited in study report): MN
- Physical state: yellow liquid
- Lot/batch No.: RV7
- Expiration date of the lot/batch: November 1995
- Stability under test conditions: stable
- Storage condition of test material: room temperature (avoid contact with strong bases and oxidizing agents)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conelli s.n.c., Arona (NO) - Italy
- Age at receipt: 2-3 months
- Weight at receipt: 2.0-3.0 kg
- Housing: individual metal cages in T06C conditioned rooms. cages were hung on metal racks over a stainless waste system. Measures of cages: 62 X 47.5 X 38 (h) cm.
- Diet (e.g. ad libitum): GLP 2RB15 certificate pelleted diet produced by Charles River Italia's feed licensee Mucedola S.r.l. (Settimo Milanese). the diet was supplemented by the producer with vitamins and trace elements. diet was provided ad libitum to the animals.
- Water (e.g. ad libitum): from the municipal water main system, periodically analyzed, and with acceptance limits within those provided in EEC Directive 80/778. Water was filtered and provided ad libitum by an automatic valve system.
- Acclimation period: about 10 weeks.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 50 ± 15 %
- Air changes (per hr): about 15/hour
- Photoperiod (hrs dark / hrs light): artificial light with a circadian cycle of 12 hours of light (7 a.m.-7 p.m.)

IN-LIFE DATES: From: June 13, 1994 To: July 22, 1994

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the contralateral eye, not treated.
Amount / concentration applied:
0.1 mL/animal
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24, 48 and 72 hours after the test article application.
Number of animals or in vitro replicates:
3 males
Details on study design:
Bothe eyes of each experimental animal selected for the testing were examined within 24 hours before testing started.
the test article was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about 3- 4 seconds in order to prevent loss of the material. The other eye (left), remaining untreated, served as control. The eyes of the test animals were washed out at 24 hours following the test article instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
48 h
Score:
1
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
72 h
Score:
0
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: sligth reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
other: slight reversible
Remarks on result:
no indication of irritation
Other effects:
No animals died during the observation period.
No clinical signs or behavioral alterations were noted in any treated rabbit.
at the direct examination of the cornea no signs were noted in any rabbit.
At the examnination after instillation of one drop of 1% sodium fluorescein no signs of corneal epihelium defect were evident in any animal.
No signs were observed in iris of any animal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance MN, when administered by ocular route to rabbits under experimental conditions adopted, was considered NOT IRRITANT for the eye.
Executive summary:

Experimental data obtained from an acute eye irritation study after a single administration of 0.1 mL of the test article MN in the New Zealand White rabbit (3 animals) are given in this report. The test method was in accordance with the EEC Guidelines (B.5) - directive 92/69/EEC and with OECD Guidelines (section 4, subpart 405, paris 1981 and subsequent revisions). for interpreting and scoring the reaction, the guide issued by the U.S. CPSC was used as reference source.

No animals died during the study. No general signs were seen in any animal. At the application site, slight reversible irritative ocular changes were observed in all treated rabbits. no signs were evident 48 -72 hours after the test article application in any animal. The test article is considered NOT IRRITANT.